510(k) K790004
K790004 is an FDA 510(k) premarket notification submitted by C-V Monitors Corp. for the device "MONITOR SCOPES, MODELS 9502, 9503". The FDA issued a decision of Substantially Equivalent on Feb 28, 1979. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. C-V Monitors Corp. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 1979
- Date Received
- Jan 2, 1979
- 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
- 510(k)