510(k) K761076
K761076 is an FDA 510(k) premarket notification submitted by Eldeco for the device "DEMODULATOR/CARDIOTACHOMETER". The FDA issued a decision of Substantially Equivalent on Dec 28, 1976. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Eldeco has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 28, 1976
- Date Received
- Nov 19, 1976
- 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)