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FDA 510(k)

ST-460 SPIRO ANALYZER SPIROMETER

K-Number: K852308 · 1985-06-24

Decision Date1985-06-24
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ST-460 SPIRO ANALYZER SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Futuremed Div. of Future Impex Corp.. It received FDA 510(k) clearance on 1985-06-24 under 510(k) number K852308. 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 ST-460 SPIRO ANALYZER SPIROMETER?

ST-460 SPIRO ANALYZER SPIROMETER is a medical device that received FDA 510(k) clearance on 1985-06-24. The listed applicant is Futuremed Div. of Future Impex Corp.. The 510(k) number is K852308.

When did ST-460 SPIRO ANALYZER SPIROMETER receive FDA 510(k) clearance?

ST-460 SPIRO ANALYZER SPIROMETER received FDA 510(k) clearance on 1985-06-24, under 510(k) number K852308.

Who is the listed applicant for ST-460 SPIRO ANALYZER SPIROMETER?

The FDA 510(k) record lists Futuremed Div. of Future Impex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST-460 SPIRO ANALYZER SPIROMETER?

The FDA product code for ST-460 SPIRO ANALYZER SPIROMETER 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.

Other records listing Futuremed Div. of Future Impex Corp. 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.

View all 17 devices →

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.

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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