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FDA 510(k)

DTAD

K-Number: K121678 · 2012-08-30

ApplicantGyrus Acmi, Inc.
Decision Date2012-08-30
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DTAD is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2012-08-30 under 510(k) number K121678. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DTAD?

DTAD is a medical device that received FDA 510(k) clearance on 2012-08-30. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K121678.

When did DTAD receive FDA 510(k) clearance?

DTAD received FDA 510(k) clearance on 2012-08-30, under 510(k) number K121678.

Who is the listed applicant for DTAD?

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

What is the FDA product code for DTAD?

The FDA product code for DTAD is ERL.

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Related Devices (Code: ERL)

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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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