The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifepak 5 Monitor, Cassette, #800923-01.
Device ID | K790757 |
510k Number | K790757 |
Device Name: | LIFEPAK 5 MONITOR, CASSETTE, #800923-01 |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-17 |
Decision Date | 1979-06-01 |