The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Observer * Central Station.
| Device ID | K972498 |
| 510k Number | K972498 |
| Device Name: | OBSERVER * CENTRAL STATION |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
| Contact | Darlene T Korab |
| Correspondent | Darlene T Korab JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1998-02-17 |
| Summary: | summary |