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FDA 510(k)

TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER

K-Number: K843996 · 1984-11-20

ApplicantEquilibrated Bio Systems, Inc.
Decision Date1984-11-20
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Equilibrated Bio Systems, Inc.. It received FDA 510(k) clearance on 1984-11-20 under 510(k) number K843996. 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 TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER?

TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER is a medical device that received FDA 510(k) clearance on 1984-11-20. The listed applicant is Equilibrated Bio Systems, Inc.. The 510(k) number is K843996.

When did TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER receive FDA 510(k) clearance?

TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER received FDA 510(k) clearance on 1984-11-20, under 510(k) number K843996.

Who is the listed applicant for TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER?

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

What is the FDA product code for TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER?

The FDA product code for TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER is BZG.

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Other records listing Equilibrated Bio Systems, 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.

K892705EBS2605 INFANT HUGGERK855102MONARK 869 ERGOMETERK791294SPIROCALK790410ADULT ZEE-FRAMEK781509ZEE-FRAMEK781386EBS 775 TONOMETER

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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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