The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Auto Dii Multi Frequency.
| Device ID | K844293 |
| 510k Number | K844293 |
| Device Name: | AUTO DII MULTI FREQUENCY |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TECHNICARE CORP. 90 INVERNESS CIRCLE EAST Englewood, CO 80112 |
| Contact | David A Ensor |
| Correspondent | David A Ensor TECHNICARE CORP. 90 INVERNESS CIRCLE EAST Englewood, CO 80112 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-05 |
| Decision Date | 1985-02-13 |