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FDA 510(k)

MODIFIED STAR CALC

K-Number: K895963 · 1990-03-16

Decision Date1990-03-16
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED STAR CALC is the device name listed in this FDA 510(k) record. The listed applicant is Infrasonics Corp.. It received FDA 510(k) clearance on 1990-03-16 under 510(k) number K895963. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED STAR CALC?

MODIFIED STAR CALC is a medical device that received FDA 510(k) clearance on 1990-03-16. The listed applicant is Infrasonics Corp.. The 510(k) number is K895963.

When did MODIFIED STAR CALC receive FDA 510(k) clearance?

MODIFIED STAR CALC received FDA 510(k) clearance on 1990-03-16, under 510(k) number K895963.

Who is the listed applicant for MODIFIED STAR CALC?

The FDA 510(k) record lists Infrasonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED STAR CALC?

The FDA product code for MODIFIED STAR CALC is BZC.

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 Infrasonics 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.

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Related Devices (Code: BZC)

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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