The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for First Beat/cardio Beat/calc.
| Device ID | K961116 |
| 510k Number | K961116 |
| Device Name: | FIRST BEAT/CARDIO BEAT/CALC |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-20 |
| Decision Date | 1996-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937002621 | K961116 | 000 |
| 00888937002515 | K961116 | 000 |
| 00888937002522 | K961116 | 000 |
| 00888937002539 | K961116 | 000 |
| 00888937002546 | K961116 | 000 |
| 00888937002553 | K961116 | 000 |
| 00888937002560 | K961116 | 000 |
| 00888937002577 | K961116 | 000 |
| 00888937002584 | K961116 | 000 |
| 00888937002591 | K961116 | 000 |
| 00888937002607 | K961116 | 000 |
| 00888937002614 | K961116 | 000 |
| 00888937002508 | K961116 | 000 |