The following data is part of a premarket notification filed by Draeget Medical Ag & Co. Kgaa with the FDA for Emg - Essential Gas Module, Model M1013a.
| Device ID | K041956 |
| 510k Number | K041956 |
| Device Name: | EMG - ESSENTIAL GAS MODULE, MODEL M1013A |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DRAEGET MEDICAL AG & CO. KGAA 3135 Quarry Road Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan DRAEGET MEDICAL AG & CO. KGAA 3135 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 | 2004-07-21 |
| Decision Date | 2004-08-09 |
| Summary: | summary |