ALERT-IT CARE ALARMS · 89-08 · UNITED KINGDOM
For ALERT-IT CARE ALARMS, import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Pulse Guard Package | Pulse Guard Package; product code is 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 84 P - - OS Physiological signal based seizure monitoring system; date published is 08/01/2019; address is Merrylees Industrial Estate , Leicester, UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- ALERT-IT CARE ALARMS verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- UNITED KINGDOM verified
- Address
- Merrylees Industrial Estate , Leicester, UNITED KINGDOM verified
- Date published
- 08/01/2019 verified
- Product code
- 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 84 P - - OS Physiological signal based seizure monitoring system each item verified
- Product
- Pulse Guard Package | Pulse Guard Package each item verified
- FDA notes
- Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580 | Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580 each item verified
What the source says
ALERT-IT CARE ALARMS Date Published : 08/01/2019 Merrylees Industrial Estate , Leicester, UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Date Published: 08/01/2019 Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580 84 P - - OS Physiological signal based seizure monitoring system Date Published: 08/01/2019 Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html