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FDA 510(k)

CCS-200 SPIROMETER

K-Number: K123896 · 2013-09-10

ApplicantBenson Medical Instruments Co.
Decision Date2013-09-10
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CCS-200 SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Benson Medical Instruments Co.. It received FDA 510(k) clearance on 2013-09-10 under 510(k) number K123896. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CCS-200 SPIROMETER?

CCS-200 SPIROMETER is a medical device that received FDA 510(k) clearance on 2013-09-10. The listed applicant is Benson Medical Instruments Co.. The 510(k) number is K123896.

When did CCS-200 SPIROMETER receive FDA 510(k) clearance?

CCS-200 SPIROMETER received FDA 510(k) clearance on 2013-09-10, under 510(k) number K123896.

Who is the listed applicant for CCS-200 SPIROMETER?

The FDA 510(k) record lists Benson Medical Instruments Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CCS-200 SPIROMETER?

The FDA product code for CCS-200 SPIROMETER is BZG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Benson Medical Instruments Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982441CCA-220K981439CCA-200K963681CCA-100 (MODIFIED)K924652BENSON CCA100

Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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