510(k) K152472
K152472 is an FDA 510(k) premarket notification submitted by Zhejiang Haisheng Medical Device Co., Ltd. for the device "Disposable Pressure Transducer". The FDA issued a decision of Substantially Equivalent on October 31, 2016. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Zhejiang Haisheng Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2016
- Date Received
- August 31, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type