The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for Ultrasound Probe Drape.
| Device ID | K940151 |
| 510k Number | K940151 |
| Device Name: | ULTRASOUND PROBE DRAPE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Contact | Bonnie Beasley |
| Correspondent | Bonnie Beasley HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1994-11-14 |