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Atmos C 361

by ATMOS MedizinTechnik GmbH & Co. KG

Atmos C 361 is a Class II device made by ATMOS MedizinTechnik GmbH & Co. KG, cleared under FDA 510(k) K090445 on 27 Feb 2009 and listed in FDA GUDID since 11 Jan 2024 (UDI-DI 04250365135169), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K090445

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04250365135169 UDI-DI Date11 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090445 Date27 Feb 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090445 decided 27 Feb 2009 Active
  • FDA GUDID UDI-DI 04250365135169 listed 11 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090445
  2. Listed FDA GUDID 04250365135169

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Atmos
Generic name
Surgical suction pump
Model / reference
C 361
Primary DI / UDI-DI
04250365135169
510(k) Number
FDA product code
BTA
GMDN term
Surgical suction pump
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

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Other devices filed under Surgical suction pump.

Other devices from ATMOS MedizinTechnik GmbH & Co. KG

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)