510(k) K960544
K960544 is an FDA 510(k) premarket notification submitted by Nasiff Assoc., Inc. for the device "CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 1996. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Nasiff Assoc., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1996
- Date Received
- February 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type