The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Ultra Cover Ultrasound Transducer Probe Covers.
| Device ID | K921695 |
| 510k Number | K921695 |
| Device Name: | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050 |
| Contact | Ann Hohensee |
| Correspondent | Ann Hohensee PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1995-02-23 |