510(k) K791959
K791959 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "POST EXTRA SYSTOLIC POSTENTLATOR". The FDA issued a decision of Substantially Equivalent on January 9, 1980. The device falls under product code IXO (Synchronizer, Ecg / Respirator, Radiographic), a Class I device regulated under 21 CFR 892.1970. Medrad, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1980
- Date Received
- October 1, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Synchronizer, Ecg / Respirator, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1970
- Review Panel
- RA
- Submission Type