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FDA 510(k)

BIOSIGN

K-Number: K872867 · 1988-07-06

ApplicantClinical Technology Corp.
Decision Date1988-07-06
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOSIGN is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Technology Corp.. It received FDA 510(k) clearance on 1988-07-06 under 510(k) number K872867. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSIGN?

BIOSIGN is a medical device that received FDA 510(k) clearance on 1988-07-06. The listed applicant is Clinical Technology Corp.. The 510(k) number is K872867.

When did BIOSIGN receive FDA 510(k) clearance?

BIOSIGN received FDA 510(k) clearance on 1988-07-06, under 510(k) number K872867.

Who is the listed applicant for BIOSIGN?

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

What is the FDA product code for BIOSIGN?

The FDA product code for BIOSIGN is FRC.

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Other records listing Clinical Technology 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.

K925080TEK-LUBEK880166BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000K872705BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)K855138BOVIE ULTRASONIC SURGICAL SYSTEMK854231ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCESK853507STERI-GRIP

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Related Devices (Code: FRC)

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.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

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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