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FDA 510(k)

DRAGER PT4000 PHOTOTHERAPY SYSTEM

K-Number: K954611 · 1995-12-01

ApplicantDrager, Inc.
Decision Date1995-12-01
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRAGER PT4000 PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Drager, Inc.. It received FDA 510(k) clearance on 1995-12-01 under 510(k) number K954611. 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 DRAGER PT4000 PHOTOTHERAPY SYSTEM?

DRAGER PT4000 PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-01. The listed applicant is Drager, Inc.. The 510(k) number is K954611.

When did DRAGER PT4000 PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

DRAGER PT4000 PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 1995-12-01, under 510(k) number K954611.

Who is the listed applicant for DRAGER PT4000 PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for DRAGER PT4000 PHOTOTHERAPY SYSTEM?

The FDA product code for DRAGER PT4000 PHOTOTHERAPY SYSTEM is LBI.

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Other records listing Drager, 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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