510(k) K942543
K942543 is an FDA 510(k) premarket notification submitted by Sankei Co., Ltd. for the device "ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS". The FDA issued a decision of Substantially Equivalent on Jul 14, 1995. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 14, 1995
- Date Received
- Apr 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type
- 510(k)