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FDA 510(k)

SPIROCARD

K-Number: K973138 · 1998-10-28

ApplicantQrs Diagnostic, LLC
Decision Date1998-10-28
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROCARD 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 1998-10-28 under 510(k) number K973138. 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 SPIROCARD?

SPIROCARD is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Qrs Diagnostic, LLC. The 510(k) number is K973138.

When did SPIROCARD receive FDA 510(k) clearance?

SPIROCARD received FDA 510(k) clearance on 1998-10-28, under 510(k) number K973138.

Who is the listed applicant for SPIROCARD?

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 SPIROCARD?

The FDA product code for SPIROCARD 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 SYSTEMK001278SENSAIRE DIAGNOSTIC SPIROMETERK001995SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

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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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