The following data is part of a premarket notification filed by Zoe Medical, Inc. with the FDA for Nightingale Monitoring System.
| Device ID | K130740 |
| 510k Number | K130740 |
| Device Name: | NIGHTINGALE MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Contact | James Chickering |
| Correspondent | James Chickering ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-19 |
| Decision Date | 2013-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851920007286 | K130740 | 000 |
| 00851920007170 | K130740 | 000 |
| 00851920007163 | K130740 | 000 |
| 00851920007040 | K130740 | 000 |