The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Autofocus Dual Element Probe.
| Device ID | K842777 |
| 510k Number | K842777 |
| Device Name: | AUTOFOCUS DUAL ELEMENT PROBE |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-16 |
| Decision Date | 1984-11-29 |