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FDA 510(k)

BIO-EMG MODEL 800

K-Number: K873947 · 1988-04-27

ApplicantBio-Research Associates, Inc.
Decision Date1988-04-27
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIO-EMG MODEL 800 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 1988-04-27 under 510(k) number K873947. 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 BIO-EMG MODEL 800?

BIO-EMG MODEL 800 is a medical device that received FDA 510(k) clearance on 1988-04-27. The listed applicant is Bio-Research Associates, Inc.. The 510(k) number is K873947.

When did BIO-EMG MODEL 800 receive FDA 510(k) clearance?

BIO-EMG MODEL 800 received FDA 510(k) clearance on 1988-04-27, under 510(k) number K873947.

Who is the listed applicant for BIO-EMG MODEL 800?

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 BIO-EMG MODEL 800?

The FDA product code for BIO-EMG MODEL 800 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-42K003176BIOEMG II AND BIOJVAK9917563 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPEK981563BIOPAK MEASUREMENT SYSTEM

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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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