The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for 5.0 Mhz Array Intravaginal Transducer.
| Device ID | K891309 |
| 510k Number | K891309 |
| Device Name: | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | John Dellinger |
| Correspondent | John Dellinger ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-05-16 |