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FDA 510(k)

LOUISVILLE LABS OXYGEN HEAD TENT

K-Number: K955535 · 1996-07-01

ApplicantLouisville Laboratories, Inc.
Decision Date1996-07-01
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LOUISVILLE LABS OXYGEN HEAD TENT is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Laboratories, Inc.. It received FDA 510(k) clearance on 1996-07-01 under 510(k) number K955535. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOUISVILLE LABS OXYGEN HEAD TENT?

LOUISVILLE LABS OXYGEN HEAD TENT is a medical device that received FDA 510(k) clearance on 1996-07-01. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K955535.

When did LOUISVILLE LABS OXYGEN HEAD TENT receive FDA 510(k) clearance?

LOUISVILLE LABS OXYGEN HEAD TENT received FDA 510(k) clearance on 1996-07-01, under 510(k) number K955535.

Who is the listed applicant for LOUISVILLE LABS OXYGEN HEAD TENT?

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

What is the FDA product code for LOUISVILLE LABS OXYGEN HEAD TENT?

The FDA product code for LOUISVILLE LABS OXYGEN HEAD TENT is CBF.

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Other records listing Louisville Laboratories, Inc. as applicant

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Related Devices (Code: CBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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