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FDA 510(k)

BIOFIND

K-Number: K003480 · 2001-05-11

ApplicantBio-Scan, Inc.
Decision Date2001-05-11
Product CodeGZO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOFIND is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Scan, Inc.. It received FDA 510(k) clearance on 2001-05-11 under 510(k) number K003480. The device is classified under product code GZO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIND?

BIOFIND is a medical device that received FDA 510(k) clearance on 2001-05-11. The listed applicant is Bio-Scan, Inc.. The 510(k) number is K003480.

When did BIOFIND receive FDA 510(k) clearance?

BIOFIND received FDA 510(k) clearance on 2001-05-11, under 510(k) number K003480.

Who is the listed applicant for BIOFIND?

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

What is the FDA product code for BIOFIND?

The FDA product code for BIOFIND is GZO.

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Other records listing Bio-Scan, 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.

K925735EEG ANALYZERK864928BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDERK841685EEG ELECTRODESK841683Q.P. PREAMPLIFIER SYSK841684BIO/SCAN BIOLOG CASSETTE RECORDER

Related Devices (Code: GZO)

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.

K131568SUDO PATHLd Technology, LLCK111308ZYTO HAND CRADLEZyto Technologies, Inc.K102166ELECTRO INTERSTITIAL SCANLd Technology, LLCK100233SUDOSCANImpeto MedicalK053004MSAS-VANTAGEBiomeridian, Int.K032935EPI-SCAN, MODEL P 100Edx Epi-Scan, Inc.

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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