The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for 8600 Vital Signs Monitor.
| Device ID | K042569 |
| 510k Number | K042569 |
| Device Name: | 8600 VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2004-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258009643 | K042569 | 000 |
| 10616258009503 | K042569 | 000 |
| 10616258009497 | K042569 | 000 |
| 00616258009483 | K042569 | 000 |
| 10616258009473 | K042569 | 000 |
| 10616258009466 | K042569 | 000 |
| 10616258009459 | K042569 | 000 |
| 10616258009442 | K042569 | 000 |
| 10616258009435 | K042569 | 000 |
| 10616258009428 | K042569 | 000 |
| 10616258009411 | K042569 | 000 |
| 10616258009404 | K042569 | 000 |
| 10616258009510 | K042569 | 000 |
| 10616258009527 | K042569 | 000 |
| 00616258009636 | K042569 | 000 |
| 00616258009629 | K042569 | 000 |
| 00616258009612 | K042569 | 000 |
| 00616258009605 | K042569 | 000 |
| 00616258009599 | K042569 | 000 |
| 00616258009582 | K042569 | 000 |
| 00616258009575 | K042569 | 000 |
| 00616258009568 | K042569 | 000 |
| 00616258009551 | K042569 | 000 |
| 10616258009541 | K042569 | 000 |
| 10616258009534 | K042569 | 000 |
| 10616258009398 | K042569 | 000 |