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FDA 510(k)

MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A

K-Number: K964820 · 1997-02-28

ApplicantUs Asia Instruments, Inc.
Decision Date1997-02-28
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A is the device name listed in this FDA 510(k) record. The listed applicant is Us Asia Instruments, Inc.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K964820. 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 MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A?

MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Us Asia Instruments, Inc.. The 510(k) number is K964820.

When did MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A receive FDA 510(k) clearance?

MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A received FDA 510(k) clearance on 1997-02-28, under 510(k) number K964820.

Who is the listed applicant for MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A?

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

What is the FDA product code for MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A?

The FDA product code for MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A is MOS.

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Other records listing Us Asia Instruments, 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.

K964753MATRIX 3000 FLEXIBLE SPINE COILK964531PROFILE 70000 QUADRATURE VOLUME NECK COILK943440PROFILE 7000 C-SPINE COIL

Related Devices (Code: MOS)

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Official Source

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