ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
FDA 510(k) clearance K942543 · decided 1995-07-14
Clearance details
- K-number
- K942543
- Device name
- ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
- Applicant
- Sankei Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-25
- Decision date
- 1995-07-14
- Days to decision
- 445 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Inverness, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.