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FDA 510(k)

TORQTECH

K-Number: K103697 · 2012-01-20

ApplicantJ. Morita USA, Inc.
Decision Date2012-01-20
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TORQTECH is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K103697. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORQTECH?

TORQTECH is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K103697.

When did TORQTECH receive FDA 510(k) clearance?

TORQTECH received FDA 510(k) clearance on 2012-01-20, under 510(k) number K103697.

Who is the listed applicant for TORQTECH?

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

What is the FDA product code for TORQTECH?

The FDA product code for TORQTECH is EGS.

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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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