The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifepak 7 Acute Cardiac Care System.
Device ID | K810154 |
510k Number | K810154 |
Device Name: | LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM |
Classification | Electrocardiograph |
Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-21 |
Decision Date | 1981-03-26 |