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FDA 510(k)

ELECTRO-MYOSCOPE 85

K-Number: K833927 · 1983-12-27

ApplicantBiomedical Design Instruments
Decision Date1983-12-27
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECTRO-MYOSCOPE 85 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Design Instruments. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833927. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO-MYOSCOPE 85?

ELECTRO-MYOSCOPE 85 is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Biomedical Design Instruments. The 510(k) number is K833927.

When did ELECTRO-MYOSCOPE 85 receive FDA 510(k) clearance?

ELECTRO-MYOSCOPE 85 received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833927.

Who is the listed applicant for ELECTRO-MYOSCOPE 85?

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

What is the FDA product code for ELECTRO-MYOSCOPE 85?

The FDA product code for ELECTRO-MYOSCOPE 85 is IKN.

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 Biomedical Design Instruments 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.

K883911ELECTRO-ACUSCOPE 85K833928MYOPULSE

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

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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