The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifepatch Ecg Electrodes.
Device ID | K790959 |
510k Number | K790959 |
Device Name: | LIFEPATCH ECG ELECTRODES |
Classification | Electrode, Electrocardiograph |
Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-22 |
Decision Date | 1979-05-31 |