Cardiovascular Analzyer
FDA 510(k) clearance K172431 · decided 2018-03-14
Clearance details
- K-number
- K172431
- Device name
- Cardiovascular Analzyer
- Applicant
- Physiowave, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-11
- Decision date
- 2018-03-14
- Days to decision
- 215 days
- Clearance type
- Traditional
- Product code
- DSB
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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| SOZO (K203473) | ImpediMed Limited | 2021-04-19 |
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| Cardiac Monitor 1500 (K191697) | Zynex Medical, Inc. | 2020-02-21 |
| ReDS System (K180479) | Sensible Medical Innovations , Ltd. | 2019-02-28 |
| SOZO (K172507) | ImpediMed Limited | 2017-12-22 |
| ECOM™ Cardiac Output Monitoring System (K172196) | Ecom Medical, Inc. | 2017-09-19 |
Recalls involving this device
No recalls on record reference this clearance.