The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Esg-300, Apu-300, Pressure Reducer, Mapc Probes.
| Device ID | K180200 |
| 510k Number | K180200 |
| Device Name: | ESG-300, APU-300, Pressure Reducer, MAPC Probes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE |
| Contact | Jan-oliver Upmeier |
| Correspondent | Dolan Mills Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761083478 | K180200 | 000 |
| 04042761083461 | K180200 | 000 |
| 04042761083454 | K180200 | 000 |
| 04042761083447 | K180200 | 000 |
| 04042761083430 | K180200 | 000 |
| 04042761083423 | K180200 | 000 |
| 04042761083416 | K180200 | 000 |
| 04042761083591 | K180200 | 000 |
| 04042761083560 | K180200 | 000 |