The following data is part of a premarket notification filed by Monica Healthcare Ltd. with the FDA for Monica An24.
| Device ID | K112390 |
| 510k Number | K112390 |
| Device Name: | MONICA AN24 |
| Classification | Uterine Electromyographic Monitor |
| Applicant | MONICA HEALTHCARE LTD. BIOCITY, PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Contact | Ian How |
| Correspondent | Ian How 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 | 2011-08-18 |
| Decision Date | 2012-07-13 |
| Summary: | summary |