SimplECG
FDA 510(k) clearance K161431 · decided 2016-11-30
Clearance details
- K-number
- K161431
- Device name
- SimplECG
- Applicant
- Nanowear, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-24
- Decision date
- 2016-11-30
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- DXH
- Device class
- 2
- Regulation number
- 870.2920
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Brooklyn, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.