Personalized Physiology Analytics Engine software
FDA 510(k) clearance K142512 · decided 2015-06-11
Clearance details
- K-number
- K142512
- Device name
- Personalized Physiology Analytics Engine software
- Applicant
- Vgbio, Inc (Dba Physiq)
- Decision
- Substantially Equivalent
- Date received
- 2014-09-08
- Decision date
- 2015-06-11
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- PLB
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Naperville, IL, US
- Third-party review
- No
- Expedited review
- No
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| TRAUMA CARE EVALUATION (K843905) | Quantitative | 1985-09-26 |
Recalls involving this device
No recalls on record reference this clearance.