The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Vsm-1 Physiological Monitor.
Device ID | K800492 |
510k Number | K800492 |
Device Name: | VSM-1 PHYSIOLOGICAL MONITOR |
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 | 1980-03-04 |
Decision Date | 1980-03-18 |