FDA 510(k)

SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645

K-Number: K122897 · 2012-12-21

Decision Date2012-12-21

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K122897. 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 SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645?

SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Invivo Corporation. The 510(k) number is K122897.

When did SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 receive FDA 510(k) clearance?

SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 received FDA 510(k) clearance on 2012-12-21, under 510(k) number K122897.

Who is the listed applicant for SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645?

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 SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645?

The FDA product code for SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 is 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.