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FDA 510(k)

AEQUITRON MED-7100 PHOTOTHERAPY LIGHT

K-Number: K850181 · 1985-04-05

ApplicantAequitron Medical, Inc.
Decision Date1985-04-05
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AEQUITRON MED-7100 PHOTOTHERAPY LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Aequitron Medical, Inc.. It received FDA 510(k) clearance on 1985-04-05 under 510(k) number K850181. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEQUITRON MED-7100 PHOTOTHERAPY LIGHT?

AEQUITRON MED-7100 PHOTOTHERAPY LIGHT is a medical device that received FDA 510(k) clearance on 1985-04-05. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K850181.

When did AEQUITRON MED-7100 PHOTOTHERAPY LIGHT receive FDA 510(k) clearance?

AEQUITRON MED-7100 PHOTOTHERAPY LIGHT received FDA 510(k) clearance on 1985-04-05, under 510(k) number K850181.

Who is the listed applicant for AEQUITRON MED-7100 PHOTOTHERAPY LIGHT?

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

What is the FDA product code for AEQUITRON MED-7100 PHOTOTHERAPY LIGHT?

The FDA product code for AEQUITRON MED-7100 PHOTOTHERAPY LIGHT is LBI.

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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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