The following data is part of a premarket notification filed by American Medical Technology, Inc. with the FDA for Ametec Masy Modular Angioscope System.
| Device ID | K905745 |
| 510k Number | K905745 |
| Device Name: | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM |
| Classification | Angioscope |
| Applicant | AMERICAN MEDICAL TECHNOLOGY, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose AMERICAN MEDICAL TECHNOLOGY, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1992-04-23 |