HEART SYNC, MODELS C-100 AND T-100
FDA 510(k) clearance K080421 · decided 2008-02-29
Clearance details
- K-number
- K080421
- Device name
- HEART SYNC, MODELS C-100 AND T-100
- Applicant
- Heart Sync, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-02-15
- Decision date
- 2008-02-29
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- Yes
- Expedited review
- No
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