The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Filter Carestar 30; Filter Safestar 55; Filter/hme Twinstar 55.
| Device ID | K072002 |
| 510k Number | K072002 |
| Device Name: | FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2008-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675249207 | K072002 | 000 |
| 04048675026785 | K072002 | 000 |
| 04048675026792 | K072002 | 000 |
| 04048675041238 | K072002 | 000 |
| 04048675041245 | K072002 | 000 |
| 04048675041276 | K072002 | 000 |
| 04048675041306 | K072002 | 000 |
| 04048675041313 | K072002 | 000 |
| 04048675041320 | K072002 | 000 |
| 04048675041337 | K072002 | 000 |
| 04048675041344 | K072002 | 000 |
| 04048675126935 | K072002 | 000 |
| 04048675026778 | K072002 | 000 |