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FDA 510(k)

SENSAIRE DIAGNOSTIC SPIROMETER

K-Number: K001278 · 2000-11-29

ApplicantQrs Diagnostic, LLC
Decision Date2000-11-29
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SENSAIRE DIAGNOSTIC SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Qrs Diagnostic, LLC. It received FDA 510(k) clearance on 2000-11-29 under 510(k) number K001278. 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 SENSAIRE DIAGNOSTIC SPIROMETER?

SENSAIRE DIAGNOSTIC SPIROMETER is a medical device that received FDA 510(k) clearance on 2000-11-29. The listed applicant is Qrs Diagnostic, LLC. The 510(k) number is K001278.

When did SENSAIRE DIAGNOSTIC SPIROMETER receive FDA 510(k) clearance?

SENSAIRE DIAGNOSTIC SPIROMETER received FDA 510(k) clearance on 2000-11-29, under 510(k) number K001278.

Who is the listed applicant for SENSAIRE DIAGNOSTIC SPIROMETER?

The FDA 510(k) record lists Qrs Diagnostic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSAIRE DIAGNOSTIC SPIROMETER?

The FDA product code for SENSAIRE DIAGNOSTIC SPIROMETER is BZG.

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Other records listing Qrs Diagnostic, LLC 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.

K083749CARDIOVIEW32 REVIEW MODULEK073630MODIFICATION TO: BPCARD, MODEL Z-7000-0700K031964BPCARDK030535EKGCARD SYSTEMK001995SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETERK973138SPIROCARD

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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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