The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Mpt 24 And Vital View 24.
Device ID | K000276 |
510k Number | K000276 |
Device Name: | MPT 24 AND VITAL VIEW 24 |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
Contact | Alex Kaplan |
Correspondent | Alex Kaplan CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-31 |
Decision Date | 2000-03-01 |