Atlas FDA

ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C

FDA 510(k) clearance K241799 · decided 2025-03-07

Clearance details

K-number
K241799
Device name
ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
Applicant
Atmos Medizintechnik GmbH & Co. KG
Decision
Substantially Equivalent
Date received
2024-06-21
Decision date
2025-03-07
Days to decision
259 days
Clearance type
Traditional
Product code
BTA
Device class
2
Regulation number
878.4780
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Lenzkirch, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.