The following data is part of a premarket notification filed by Linde Healthcare Ab with the FDA for Sedara Gas Mixer, Sedara Scavenger Model: 03, 04.
| Device ID | K101286 |
| 510k Number | K101286 |
| Device Name: | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | LINDE HEALTHCARE AB AGAVAGEN 54 Lidingo, SE Se 18181 |
| Contact | Anders Palm |
| Correspondent | Anders Palm LINDE HEALTHCARE AB AGAVAGEN 54 Lidingo, SE Se 18181 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-05-07 |
| Decision Date | 2011-10-20 |
| Summary: | summary |