The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for True Spectrum Analysis/mark Iv Duplex.
| Device ID | K801972 |
| 510k Number | K801972 |
| Device Name: | TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-19 |
| Decision Date | 1980-10-23 |