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FDA 510(k)

AUTOSPIROMETER HI-498

K-Number: K820599 · 1982-04-15

ApplicantMedical Equipment Designs, Inc.
Decision Date1982-04-15
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOSPIROMETER HI-498 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Designs, Inc.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820599. 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 AUTOSPIROMETER HI-498?

AUTOSPIROMETER HI-498 is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Medical Equipment Designs, Inc.. The 510(k) number is K820599.

When did AUTOSPIROMETER HI-498 receive FDA 510(k) clearance?

AUTOSPIROMETER HI-498 received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820599.

Who is the listed applicant for AUTOSPIROMETER HI-498?

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

What is the FDA product code for AUTOSPIROMETER HI-498?

The FDA product code for AUTOSPIROMETER HI-498 is BZG.

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Other records listing Medical Equipment Designs, Inc. as applicant

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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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