The following data is part of a premarket notification filed by Monica Healthcare Ltd. with the FDA for Monica Novii Wireless Patch System.
| Device ID | K140862 |
| 510k Number | K140862 |
| Device Name: | MONICA NOVII WIRELESS PATCH SYSTEM |
| Classification | Uterine Electromyographic Monitor |
| Applicant | MONICA HEALTHCARE LTD. BIOCITY, PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Contact | Carl Barratt |
| Correspondent | Carl Barratt MONICA HEALTHCARE LTD. BIOCITY, PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Product Code | OSP |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682142731 | K140862 | 000 |
| 00840682142700 | K140862 | 000 |