510(k) K790213
K790213 is an FDA 510(k) premarket notification submitted by Amr Co. for the device "GENERATOR, R-WAVE". The FDA issued a decision of Substantially Equivalent on March 22, 1979. The device falls under product code IYY (Synchronizer, Electrocardiograph, Nuclear), a Class I device regulated under 21 CFR 892.1410.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1979
- Date Received
- January 30, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Synchronizer, Electrocardiograph, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1410
- Review Panel
- RA
- Submission Type