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FDA 510(k)

HARMONY LED-1 SURGICAL LIGHTING SYSTEM

K-Number: K072072 · 2007-10-05

ApplicantSTERIS Corporation
Decision Date2007-10-05
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HARMONY LED-1 SURGICAL LIGHTING 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 2007-10-05 under 510(k) number K072072. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARMONY LED-1 SURGICAL LIGHTING SYSTEM?

HARMONY LED-1 SURGICAL LIGHTING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is STERIS Corporation. The 510(k) number is K072072.

When did HARMONY LED-1 SURGICAL LIGHTING SYSTEM receive FDA 510(k) clearance?

HARMONY LED-1 SURGICAL LIGHTING SYSTEM received FDA 510(k) clearance on 2007-10-05, under 510(k) number K072072.

Who is the listed applicant for HARMONY LED-1 SURGICAL LIGHTING 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 HARMONY LED-1 SURGICAL LIGHTING SYSTEM?

The FDA product code for HARMONY LED-1 SURGICAL LIGHTING SYSTEM is FSY.

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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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