510(k) K230931 · BSZ Gas-Machine, Anesthesia
Atlan
| Applicant | Drägerwerk AG Co. Kgaa, Luebeck, DE |
| Decision | Substantially Equivalent, Jul 23, 2023 |
| Received | Apr 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2026 | Draeger, Inc. Atlan A350. Model Number: 8211500. anesthesia workstation Open, Classified |
BSZ | None listed |
| Jun 4, 2026 | Draeger, Inc. Atlan A350XL. Model Number: 8621600. anesthesia workstation Open, Classified |
BSZ | None listed |
| Oct 1, 2025 | Draeger, Inc. Brand Name: Atlan
Product Name: Atlan A350
Model/Catalog Number: 8211500
Software Version: Not applicable
Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing Open, Classified |
BSZ | None listed |
| Oct 1, 2025 | Draeger, Inc. Brand Name: Atlan
Product Name: Atlan A350XL
Model/Catalog Number: 8621600
Software Version: Not Applicable
Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizin Open, Classified |
BSZ | None listed |
| Dec 18, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A300
Model/Catalog Number: 8211300
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Open, Classified |
BSZ | None listed |
| Dec 18, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A300XL
Model/Catalog Number: 8621400
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Open, Classified |
BSZ | None listed |
| Nov 13, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A350
Model/Catalog Number: 8211500
Software Version: Not applicable
Component: Not applicable Open, Classified |
BSZ | None listed |
| Nov 13, 2024 | Draeger Medical, Inc. Brand Name: Atlan
Product Name: Atlan A350XL
Model/Catalog Number: 8621600
Software Version: Not Applicable
Component: Not applicable Open, Classified |
BSZ | None listed |
| Feb 1, 2024 | Draegerwerk Ag & Co. Kgaa Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and
8621600 (Atlan A350 XL) Open, Classified |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.