510(k) K780117
K780117 is an FDA 510(k) premarket notification submitted by Med General for the device "CARDIOMETER". The FDA issued a decision of Substantially Equivalent on February 3, 1978. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Med General has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1978
- Date Received
- January 23, 1978
- 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