The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Vital Signs Monitor 3.
Device ID | K833584 |
510k Number | K833584 |
Device Name: | VITAL SIGNS MONITOR 3 |
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 | 1983-10-12 |
Decision Date | 1984-01-30 |