The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for 5.0 Mhz Convex Array Intravaginal Transducer.
| Device ID | K895647 |
| 510k Number | K895647 |
| Device Name: | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | J Sweeney |
| Correspondent | J Sweeney ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-12-18 |