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Ccs-200

by Benson Medical Instruments Co.

Ccs-200 is a Class II device made by Benson Medical Instruments Co., cleared under FDA 510(k) K123896 on 10 Sep 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI B2075003470), 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) K123896

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 NumberB2075003470 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123896 Date10 Sep 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123896 decided 10 Sep 2013 Active
  • FDA GUDID UDI-DI B2075003470 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123896
  2. Listed FDA GUDID B2075003470

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Diagnostic spirometer, professional
Model / Ref / Catalog
CCS-200
Primary DI / UDI-DI
B2075003470
510(k) Number
FDA product code
BZG
GMDN term
Diagnostic spirometer, professional
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution

Related devices

Category: Diagnostic spirometer, professional

Cleared under the same submission (K123896)

Similar devices in this category

Other devices filed under Diagnostic spirometer, professional.

Other devices from Benson Medical Instruments Co.

See all devices from Benson Medical Instruments Co. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)