510(k) K842388
K842388 is an FDA 510(k) premarket notification submitted by Takeda Medical, Inc. for the device "COPAL DIGITAL SPHYGMOMANOMETER UA-510". The FDA issued a decision of Substantially Equivalent on Feb 13, 1985. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Takeda Medical, Inc. has 10 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 1985
- Date Received
- Jun 18, 1984
- 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)