The following data is part of a premarket notification filed by Zoe Medical, Inc. with the FDA for Ultraview Dm3 Monitor.
| Device ID | K093802 |
| 510k Number | K093802 |
| Device Name: | ULTRAVIEW DM3 MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Contact | Jim Chickering |
| Correspondent | Jim Chickering ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-11 |
| Decision Date | 2010-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851920007033 | K093802 | 000 |
| 00851920007026 | K093802 | 000 |
| 00851920007019 | K093802 | 000 |
| 00851920007002 | K093802 | 000 |
| 10841522125997 | K093802 | 000 |
| 10841522125980 | K093802 | 000 |
| 10841522105050 | K093802 | 000 |
| 10841522105036 | K093802 | 000 |
| 10841522105005 | K093802 | 000 |