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FDA 510(k)

GEM, MODEL 004110

K-Number: K030464 · 2003-03-14

ApplicantCollins Medical, Inc.
Decision Date2003-03-14
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GEM, MODEL 004110 is the device name listed in this FDA 510(k) record. The listed applicant is Collins Medical, Inc.. It received FDA 510(k) clearance on 2003-03-14 under 510(k) number K030464. 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 GEM, MODEL 004110?

GEM, MODEL 004110 is a medical device that received FDA 510(k) clearance on 2003-03-14. The listed applicant is Collins Medical, Inc.. The 510(k) number is K030464.

When did GEM, MODEL 004110 receive FDA 510(k) clearance?

GEM, MODEL 004110 received FDA 510(k) clearance on 2003-03-14, under 510(k) number K030464.

Who is the listed applicant for GEM, MODEL 004110?

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

What is the FDA product code for GEM, MODEL 004110?

The FDA product code for GEM, MODEL 004110 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 Collins Medical, 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.

K030917GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130K011344INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400K992743COLLINS CPL

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

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

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