K940152 is an FDA 510(k) clearance for the CAMERA COVER WITH TEAR TIP. This device is classified as a Accessories, Photographic, For Endoscope (exclude Light Sources) (Class I - General Controls, product code FEM).
Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on October 28, 1994, 298 days after receiving the submission on January 3, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K940152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1994 |
| Decision Date | October 28, 1994 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEM — Accessories, Photographic, For Endoscope (exclude Light Sources) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1500 |