510(k) K790394
K790394 is an FDA 510(k) premarket notification submitted by Physio-Control Corp. for the device "DEFIBRILLATOR INTERAL PADDLE TEST LOAD". The FDA issued a decision of Substantially Equivalent on March 23, 1979. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Physio-Control Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1979
- Date Received
- February 26, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Defibrillator
- Device Class
- Class II
- Regulation Number
- 870.5325
- Review Panel
- CV
- Submission Type