FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
HEART SYNC
K Number: K131494
·
Decision Sep 16, 2013
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
3
Review Days
116
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Basic Information
- Device Name
- HEART SYNC
- K Number
- K131494
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heart Sync, Inc.
- Date Received
- May 23, 2013
- Decision Date
- September 16, 2013
- Product Code
- MKJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |
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