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FDA 510(k)

GS-MODULAR (GOLD STANDARD - MODULAR)

K-Number: K925459 · 1994-02-04

ApplicantWarren E. Collins, Inc.
Decision Date1994-02-04
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GS-MODULAR (GOLD STANDARD - MODULAR) is the device name listed in this FDA 510(k) record. The listed applicant is Warren E. Collins, Inc.. It received FDA 510(k) clearance on 1994-02-04 under 510(k) number K925459. 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 GS-MODULAR (GOLD STANDARD - MODULAR)?

GS-MODULAR (GOLD STANDARD - MODULAR) is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Warren E. Collins, Inc.. The 510(k) number is K925459.

When did GS-MODULAR (GOLD STANDARD - MODULAR) receive FDA 510(k) clearance?

GS-MODULAR (GOLD STANDARD - MODULAR) received FDA 510(k) clearance on 1994-02-04, under 510(k) number K925459.

Who is the listed applicant for GS-MODULAR (GOLD STANDARD - MODULAR)?

The FDA 510(k) record lists Warren E. Collins, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GS-MODULAR (GOLD STANDARD - MODULAR)?

The FDA product code for GS-MODULAR (GOLD STANDARD - MODULAR) is BZG.

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Other records listing Warren E. Collins, Inc. 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.

K912946COLLINS DIGITAL PULMONARY MANOMETERK871151THE SPIRA ELEKTRO 2K861227COLLINS PNEUMOTACH PFT SYSTEMK852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMK831780METABOLIC EXERCISE TESTING SYSTEMK831778RS-RESIDUAL VOLUME SYSTEM

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Related Devices (Code: BZG)

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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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