PulseGuard International Ltd · 89-08 · UNITED KINGDOM
For PulseGuard International Ltd · 89-08 · UNITED KINGDOM, import alert is 89-08; 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)"; country is UNITED KINGDOM; 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 Unit 1, Crown Yard, Bedgebury Rd , Goudhurst, Kent UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- PulseGuard International Ltd 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
- Unit 1, Crown Yard, Bedgebury Rd , Goudhurst, Kent 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
PulseGuard International Ltd Date Published : 08/01/2019 Unit 1, Crown Yard, Bedgebury Rd , Goudhurst, Kent UNITED KINGDOM 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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