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FDA 510(k)

AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM

K-Number: K013242 · 2001-12-13

ApplicantSTERIS Corporation
Decision Date2001-12-13
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K013242. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM?

AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is STERIS Corporation. The 510(k) number is K013242.

When did AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM receive FDA 510(k) clearance?

AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM received FDA 510(k) clearance on 2001-12-13, under 510(k) number K013242.

Who is the listed applicant for AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM?

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

What is the FDA product code for AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM?

The FDA product code for AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM is FTD.

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Related Devices (Code: FTD)

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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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