510(k) K790394

DEFIBRILLATOR INTERAL PADDLE TEST LOAD by Physio-Control Corp. — Product Code DRL

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