The following data is part of a premarket notification filed by Zoe Medical, Inc. with the FDA for Zoe Medical Nightingale Monitoring System.
| Device ID | K001775 |
| 510k Number | K001775 |
| Device Name: | ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Contact | Paul M Fitzmeyer |
| Correspondent | Paul M Fitzmeyer ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-12 |
| Decision Date | 2001-01-12 |