FDA 510(k)

MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS

K-Number: K053017 · 2005-11-16

Decision Date2005-11-16

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2005-11-16 under 510(k) number K053017. 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 MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS?

MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS is a medical device that received FDA 510(k) clearance on 2005-11-16. The listed applicant is Invivo Corporation. The 510(k) number is K053017.

When did MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS receive FDA 510(k) clearance?

MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS received FDA 510(k) clearance on 2005-11-16, under 510(k) number K053017.

Who is the listed applicant for MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS?

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

What is the FDA product code for MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS?

The FDA product code for MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS is MOS.

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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.