The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Polaris 95000-a Bedside/transport Monitor.
| Device ID | K031124 |
| 510k Number | K031124 |
| Device Name: | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATEX-OHMEDA, INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Contact | Al Van Houdt |
| Correspondent | Al Van Houdt DATEX-OHMEDA, INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Product Code | MHX |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-08 |
| Decision Date | 2003-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522126444 | K031124 | 000 |
| 30841522126257 | K031124 | 000 |
| 30841522126264 | K031124 | 000 |
| 30841522126271 | K031124 | 000 |
| 30841522126295 | K031124 | 000 |
| 30841522126301 | K031124 | 000 |
| 30841522126318 | K031124 | 000 |
| 30841522126325 | K031124 | 000 |
| 30841522126332 | K031124 | 000 |
| 30841522126356 | K031124 | 000 |
| 30841522126363 | K031124 | 000 |
| 30841522126370 | K031124 | 000 |
| 30841522126394 | K031124 | 000 |
| 30841522126400 | K031124 | 000 |
| 10841522126420 | K031124 | 000 |
| 10841522126437 | K031124 | 000 |
| 10841522112430 | K031124 | 000 |