The following data is part of a premarket notification filed by Vickers Ltd. with the FDA for Vickers Medical Model 271 Heart Rate Monitor.
| Device ID | K854597 |
| 510k Number | K854597 |
| Device Name: | VICKERS MEDICAL MODEL 271 HEART RATE MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | VICKERS LTD. PRIESTLEY ROAD BASINGSTOKE HAMPSHIRE England, GB Rg249np |
| Contact | Cantrill |
| Correspondent | Cantrill VICKERS LTD. PRIESTLEY ROAD BASINGSTOKE HAMPSHIRE England, GB Rg249np |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1986-05-09 |