The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Mk 700 Ultrasound System.
| Device ID | K842093 |
| 510k Number | K842093 |
| Device Name: | MK 700 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. P.O. BOX 6639 Bellevue, WA 98008 |
| Contact | Francis G Smith |
| Correspondent | Francis G Smith ADVANCED TECHNOLOGY LABORATORIES, INC. P.O. BOX 6639 Bellevue, WA 98008 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-24 |
| Decision Date | 1984-09-27 |