The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifepak 7p.
Device ID | K832876 |
510k Number | K832876 |
Device Name: | LIFEPAK 7P |
Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRO |
CFR Regulation Number | 870.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-26 |
Decision Date | 1984-01-30 |