The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Cadence Doppler Ultrasound System.
| Device ID | K991441 |
| 510k Number | K991441 |
| Device Name: | CADENCE DOPPLER ULTRASOUND SYSTEM |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | MEDASONICS, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Contact | William E Mckay |
| Correspondent | William E Mckay MEDASONICS, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937019858 | K991441 | 000 |
| 00888937011340 | K991441 | 000 |
| 00888937011333 | K991441 | 000 |