The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for Transducer Positioner.
| Device ID | K973622 |
| 510k Number | K973622 |
| Device Name: | TRANSDUCER POSITIONER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Contact | Rick L Pruter |
| Correspondent | Rick L Pruter PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-23 |
| Decision Date | 1997-11-26 |