The following data is part of a premarket notification filed by Gimmi Gmbh with the FDA for Gimmi Alpha Hysteroscopes & Accessories, Models E.8xxx.xx, T.8xxx.xx, Zxxx.xx,s.xxxx.xx, K0142.25.
| Device ID | K012869 |
| 510k Number | K012869 |
| Device Name: | GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GIMMI GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser GIMMI GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Product Code | HIH |
| Subsequent Product Code | HDC |
| Subsequent Product Code | HET |
| Subsequent Product Code | HHO |
| Subsequent Product Code | KNA |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-27 |
| Decision Date | 2002-03-11 |
| Summary: | summary |