510(k) K896633
K896633 is an FDA 510(k) premarket notification submitted by U.S. Medical Corp. for the device "AUTO-CUFF(TM)". The FDA issued a decision of Substantially Equivalent on February 1, 1990. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. U.S. Medical Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1990
- Date Received
- November 22, 1989
- 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