The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Obtrasound Stethoscope Fetal Calc.
| Device ID | K911453 |
| 510k Number | K911453 |
| Device Name: | OBTRASOUND STETHOSCOPE FETAL CALC |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | MEDASONICS, INC. 47233 FREMONT BLVD. P.O. BOX 4903 Fremont, CA 94538 |
| Contact | Keith V Rohrbach |
| Correspondent | Keith V Rohrbach MEDASONICS, INC. 47233 FREMONT BLVD. P.O. BOX 4903 Fremont, CA 94538 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-06-20 |