The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Infinity Mcable - Mainstream Co2.
| Device ID | K100941 |
| 510k Number | K100941 |
| Device Name: | INFINITY MCABLE - MAINSTREAM CO2 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE Luebeck, DE D-23542 |
| Contact | Ulrich Schroeder |
| Correspondent | Ulrich Schroeder DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE Luebeck, DE D-23542 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-05 |
| Decision Date | 2010-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675225140 | K100941 | 000 |
| 04048675421603 | K100941 | 000 |
| 04048675421597 | K100941 | 000 |