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FDA 510(k)

HM-SPIRO

K-Number: K951718 · 1995-12-20

Decision Date1995-12-20
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HM-SPIRO is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Med, Inc.. It received FDA 510(k) clearance on 1995-12-20 under 510(k) number K951718. 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 HM-SPIRO?

HM-SPIRO is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Hill-Med, Inc.. The 510(k) number is K951718.

When did HM-SPIRO receive FDA 510(k) clearance?

HM-SPIRO received FDA 510(k) clearance on 1995-12-20, under 510(k) number K951718.

Who is the listed applicant for HM-SPIRO?

The FDA 510(k) record lists Hill-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HM-SPIRO?

The FDA product code for HM-SPIRO 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 Hill-Med, 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.

View all 10 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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