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FDA 510(k)

ENGLER 25K SERIES ULTRASONIC INSERTS

K-Number: K122748 · 2013-06-11

ApplicantEngler Engineering Corp.
Decision Date2013-06-11
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENGLER 25K SERIES ULTRASONIC INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is Engler Engineering Corp.. It received FDA 510(k) clearance on 2013-06-11 under 510(k) number K122748. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGLER 25K SERIES ULTRASONIC INSERTS?

ENGLER 25K SERIES ULTRASONIC INSERTS is a medical device that received FDA 510(k) clearance on 2013-06-11. The listed applicant is Engler Engineering Corp.. The 510(k) number is K122748.

When did ENGLER 25K SERIES ULTRASONIC INSERTS receive FDA 510(k) clearance?

ENGLER 25K SERIES ULTRASONIC INSERTS received FDA 510(k) clearance on 2013-06-11, under 510(k) number K122748.

Who is the listed applicant for ENGLER 25K SERIES ULTRASONIC INSERTS?

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

What is the FDA product code for ENGLER 25K SERIES ULTRASONIC INSERTS?

The FDA product code for ENGLER 25K SERIES ULTRASONIC INSERTS is ELC.

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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.

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