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FDA 510(k)

MODELS 190GE-64/191GE-64/192GE-64/193GE-64

K-Number: K914536 · 1991-11-27

ApplicantMedical Advances, Inc.
Decision Date1991-11-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODELS 190GE-64/191GE-64/192GE-64/193GE-64 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Advances, Inc.. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K914536. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS 190GE-64/191GE-64/192GE-64/193GE-64?

MODELS 190GE-64/191GE-64/192GE-64/193GE-64 is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Medical Advances, Inc.. The 510(k) number is K914536.

When did MODELS 190GE-64/191GE-64/192GE-64/193GE-64 receive FDA 510(k) clearance?

MODELS 190GE-64/191GE-64/192GE-64/193GE-64 received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914536.

Who is the listed applicant for MODELS 190GE-64/191GE-64/192GE-64/193GE-64?

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

What is the FDA product code for MODELS 190GE-64/191GE-64/192GE-64/193GE-64?

The FDA product code for MODELS 190GE-64/191GE-64/192GE-64/193GE-64 is LNH.

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Other records listing Medical Advances, 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.

K023084MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COILK021433MODEL 415PH-64/42: PHASED ARRAY SHOULDER COILK011608MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COILK010074MODEL 455GE PHASED ARRAY WRIST COILK003685MODEL 342GE-64 HIGH RESOLUTION BRAIN COILK003144MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL

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Related Devices (Code: LNH)

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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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