SUMMED INFLATION DEVICE KIT
FDA 510(k) clearance K133795 · decided 2014-12-12
Clearance details
- K-number
- K133795
- Device name
- SUMMED INFLATION DEVICE KIT
- Applicant
- Sunny Medical Device (Shenzhen) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-13
- Decision date
- 2014-12-12
- Days to decision
- 364 days
- Clearance type
- Traditional
- Product code
- MAV
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.