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FDA 510(k)

DUO-LITE PHOTOTHERAPY SYSTEM

K-Number: K971256 · 1997-09-24

ApplicantAir-Shields, Inc.
Decision Date1997-09-24
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUO-LITE PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1997-09-24 under 510(k) number K971256. 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 DUO-LITE PHOTOTHERAPY SYSTEM?

DUO-LITE PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-24. The listed applicant is Air-Shields, Inc.. The 510(k) number is K971256.

When did DUO-LITE PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

DUO-LITE PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 1997-09-24, under 510(k) number K971256.

Who is the listed applicant for DUO-LITE PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for DUO-LITE PHOTOTHERAPY SYSTEM?

The FDA product code for DUO-LITE PHOTOTHERAPY SYSTEM is LBI.

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Other records listing Air-Shields, Inc. as applicant

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Related Devices (Code: 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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