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FDA 510(k)

ALTOMEC ARTHROSCOPE

K-Number: K112548 · 2012-08-15

ApplicantAltomec Endoscopy, Inc.
Decision Date2012-08-15
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTOMEC ARTHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Altomec Endoscopy, Inc.. It received FDA 510(k) clearance on 2012-08-15 under 510(k) number K112548. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTOMEC ARTHROSCOPE?

ALTOMEC ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 2012-08-15. The listed applicant is Altomec Endoscopy, Inc.. The 510(k) number is K112548.

When did ALTOMEC ARTHROSCOPE receive FDA 510(k) clearance?

ALTOMEC ARTHROSCOPE received FDA 510(k) clearance on 2012-08-15, under 510(k) number K112548.

Who is the listed applicant for ALTOMEC ARTHROSCOPE?

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

What is the FDA product code for ALTOMEC ARTHROSCOPE?

The FDA product code for ALTOMEC ARTHROSCOPE is HRX.

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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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