The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Defibrillator Interal Paddle Test Load.
Device ID | K790394 |
510k Number | K790394 |
Device Name: | DEFIBRILLATOR INTERAL PADDLE TEST LOAD |
Classification | Tester, Defibrillator |
Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRL |
CFR Regulation Number | 870.5325 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-26 |
Decision Date | 1979-03-23 |