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FDA 510(k)

BIOEMG II AND BIOJVA

K-Number: K003176 · 2001-01-04

ApplicantBio-Research Associates, Inc.
Decision Date2001-01-04
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOEMG II AND BIOJVA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Research Associates, Inc.. It received FDA 510(k) clearance on 2001-01-04 under 510(k) number K003176. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOEMG II AND BIOJVA?

BIOEMG II AND BIOJVA is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Bio-Research Associates, Inc.. The 510(k) number is K003176.

When did BIOEMG II AND BIOJVA receive FDA 510(k) clearance?

BIOEMG II AND BIOJVA received FDA 510(k) clearance on 2001-01-04, under 510(k) number K003176.

Who is the listed applicant for BIOEMG II AND BIOJVA?

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

What is the FDA product code for BIOEMG II AND BIOJVA?

The FDA product code for BIOEMG II AND BIOJVA is KZM.

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Other records listing Bio-Research Associates, 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.

K130158M-SCANK082927BIOEMG IIIK061799QUADRATENS, MODEL QT-42K9917563 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPEK981563BIOPAK MEASUREMENT SYSTEMK952218JT-3 ELECTROGNATHOGRAPH

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Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K030869BITESTRIPS.L.P. , Ltd.

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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