The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifestat 200.
Device ID | K831232 |
510k Number | K831232 |
Device Name: | LIFESTAT 200 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PHYSIO-CONTROL CORP. WA |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-15 |
Decision Date | 1983-07-28 |