510(k) K972795
K972795 is an FDA 510(k) premarket notification submitted by Nasiff Assoc., Inc. for the device "CARDIO-CARD MANAGEMENT SYSTEM II". The FDA issued a decision of Substantially Equivalent on February 20, 1998. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Nasiff Assoc., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1998
- Date Received
- July 28, 1997
- 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