The following data is part of a premarket notification filed by Monica Healthcare with the FDA for Monica If24.
| Device ID | K112163 |
| 510k Number | K112163 |
| Device Name: | MONICA IF24 |
| Classification | Uterine Electromyographic Monitor |
| Applicant | MONICA HEALTHCARE PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Contact | Ian How |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | OSP |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-07-27 |
| Decision Date | 2011-08-30 |
| Summary: | summary |