The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Vital Signs Monitor.
| Device ID | K101602 |
| 510k Number | K101602 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | Monitor, St Segment With Alarm |
| 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 | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-09-01 |
| Summary: | summary |