The following data is part of a premarket notification filed by A. Stein - Regulatory Affairs Consulting with the FDA for Ec-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7p (pal) & Ec 1000-7n (ntsc).
| Device ID | K982754 |
| 510k Number | K982754 |
| Device Name: | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | A. STEIN - REGULATORY AFFAIRS CONSULTING P.O.B. 454 Ginot Shomron, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. STEIN - REGULATORY AFFAIRS CONSULTING P.O.B. 454 Ginot Shomron, IL 44853 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1999-01-08 |