FDA 510(k)

MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY

K-Number: K983109 · 1998-10-06

Decision Date1998-10-06

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY 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 1998-10-06 under 510(k) number K983109. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY?

MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY is a medical device that received FDA 510(k) clearance on 1998-10-06. The listed applicant is Medical Advances, Inc.. The 510(k) number is K983109.

When did MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY receive FDA 510(k) clearance?

MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY received FDA 510(k) clearance on 1998-10-06, under 510(k) number K983109.

Who is the listed applicant for MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY?

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 MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY?

The FDA product code for MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY is MOS.

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Other records listing Medical Advances, Inc. as applicant

K023084MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL K021433MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL K011608MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL K010074MODEL 455GE PHASED ARRAY WRIST COIL K003685MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL K003144MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL

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Related Devices (Code: MOS)

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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.