Biovitals Analytics Engine
FDA 510(k) clearance K183282 · decided 2019-08-15
Clearance details
- K-number
- K183282
- Device name
- Biovitals Analytics Engine
- Applicant
- Biofourmis Singapore Pte., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-26
- Decision date
- 2019-08-15
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- PLB
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Singapore, SG
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.