The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Vital Signs Monitor W/arrhythmia Detection And St Analysis, Model 8100.
| Device ID | K030613 |
| 510k Number | K030613 |
| Device Name: | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-26 |
| Decision Date | 2003-04-17 |
| Summary: | summary |