The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for 506cn Patient Monitor.
| Device ID | K091050 |
| 510k Number | K091050 |
| Device Name: | 506CN PATIENT MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2009-05-27 |
| Summary: | summary |