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FDA 510(k)

PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO

K-Number: K840454 · 1984-03-23

ApplicantAir-Shields, Inc.
Decision Date1984-03-23
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO 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 1984-03-23 under 510(k) number K840454. 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 PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO?

PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Air-Shields, Inc.. The 510(k) number is K840454.

When did PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO receive FDA 510(k) clearance?

PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840454.

Who is the listed applicant for PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO?

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 PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO?

The FDA product code for PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO is LBI.

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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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