Disposable Pressure Transducer
FDA 510(k) clearance K152472 · decided 2016-10-31
Clearance details
- K-number
- K152472
- Device name
- Disposable Pressure Transducer
- Applicant
- Zhejiang Haisheng Medical Device Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-31
- Decision date
- 2016-10-31
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shaoxing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.