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FDA 510(k)

BIOTRON 18

K-Number: K771534 · 1977-08-26

ApplicantBiotronics Corp.
Decision Date1977-08-26
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOTRON 18 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronics Corp.. It received FDA 510(k) clearance on 1977-08-26 under 510(k) number K771534. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRON 18?

BIOTRON 18 is a medical device that received FDA 510(k) clearance on 1977-08-26. The listed applicant is Biotronics Corp.. The 510(k) number is K771534.

When did BIOTRON 18 receive FDA 510(k) clearance?

BIOTRON 18 received FDA 510(k) clearance on 1977-08-26, under 510(k) number K771534.

Who is the listed applicant for BIOTRON 18?

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

What is the FDA product code for BIOTRON 18?

The FDA product code for BIOTRON 18 is QJQ.

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.

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Other records listing Biotronics 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.

K860551ETP 180 CARDIAC PACEMAKER (EXTERNAL)

Related Devices (Code: QJQ)

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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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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