The following data is part of a premarket notification filed by Medical Accessories, Inc. with the FDA for Pocket Size Fetal Heart Detector.
| Device ID | K920056 |
| 510k Number | K920056 |
| Device Name: | POCKET SIZE FETAL HEART DETECTOR |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | MEDICAL ACCESSORIES, INC. 92 YOUNGS RD. Trenton, NJ 08619 |
| Contact | Janis Ziedonis |
| Correspondent | Janis Ziedonis MEDICAL ACCESSORIES, INC. 92 YOUNGS RD. Trenton, NJ 08619 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-06 |
| Decision Date | 1992-12-11 |