The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Mark V Duplex Ultrasonic Scan Sys..
| Device ID | K802438 |
| 510k Number | K802438 |
| Device Name: | MARK V DUPLEX ULTRASONIC SCAN SYS. |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-06 |
| Decision Date | 1981-01-21 |