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FDA 510(k)

DYNAMIC WEDGE

K-Number: K970564 · 1997-05-12

ApplicantMitsubishi Electronics America, Inc.
Decision Date1997-05-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DYNAMIC WEDGE is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Electronics America, Inc.. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K970564. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAMIC WEDGE?

DYNAMIC WEDGE is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Mitsubishi Electronics America, Inc.. The 510(k) number is K970564.

When did DYNAMIC WEDGE receive FDA 510(k) clearance?

DYNAMIC WEDGE received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970564.

Who is the listed applicant for DYNAMIC WEDGE?

The FDA 510(k) record lists Mitsubishi Electronics America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAMIC WEDGE?

The FDA product code for DYNAMIC WEDGE is IYE.

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Other records listing Mitsubishi Electronics America, Inc. as applicant

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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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