The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kgaa with the FDA for Intellivue Gas Modules, Models G5 M1019a And G1 M1013a.
| Device ID | K053204 |
| 510k Number | K053204 |
| Device Name: | INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DRAEGER MEDICAL AG & CO. KGAA 3155 QUARRY ROAD Telford, PA 18969 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante DRAEGER MEDICAL AG & CO. KGAA 3155 QUARRY ROAD Telford, PA 18969 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-16 |
| Decision Date | 2006-02-03 |
| Summary: | summary |