The following data is part of a premarket notification filed by Drägerwerk Ag & Co. Kgaa with the FDA for Filter Carestar Plus, Filter Safestar Plus, Filter/hme Twinstar Plus.
| Device ID | K221836 |
| 510k Number | K221836 |
| Device Name: | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 Lüebeck, DE 23542 |
| Contact | Luise Lang |
| Correspondent | Luise Lang Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 Lüebeck, DE 23542 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-23 |
| Decision Date | 2022-12-07 |