The following data is part of a premarket notification filed by Medadonics, Inc. with the FDA for Ultrasound Stethoscope(r) Intradop(r).
| Device ID | K912033 |
| 510k Number | K912033 |
| Device Name: | ULTRASOUND STETHOSCOPE(R) INTRADOP(R) |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | MEDADONICS, INC. 47233 FREMONT BLVD. P.O. BOX 4903 Fremont, CA 94539 |
| Contact | Keith V.rohrbach |
| Correspondent | Keith V.rohrbach MEDADONICS, INC. 47233 FREMONT BLVD. P.O. BOX 4903 Fremont, CA 94539 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-09 |
| Decision Date | 1991-10-15 |