The following data is part of a premarket notification filed by W.o.m. World Of Medicine Gmbh with the FDA for Hd-camera Hdc1000.
| Device ID | K152109 |
| 510k Number | K152109 |
| Device Name: | HD-Camera HDC1000 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | W.O.M. WORLD OF MEDICINE GmbH Salzufer 8 Berlin, DE 10587 |
| Contact | Soeren Markworth |
| Correspondent | Susanne Raab Susan Raab 1480 Cambridge Street Cambridge, MA 02139 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-29 |
| Decision Date | 2015-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702003159 | K152109 | 000 |
| 04056702003142 | K152109 | 000 |
| 04056702003128 | K152109 | 000 |
| 04056702003111 | K152109 | 000 |