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FDA 510(k)

LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT

K-Number: K884018 · 1989-02-27

ApplicantLamelli Pulmonary Research Center
Decision Date1989-02-27
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT is the device name listed in this FDA 510(k) record. The listed applicant is Lamelli Pulmonary Research Center. It received FDA 510(k) clearance on 1989-02-27 under 510(k) number K884018. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT?

LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Lamelli Pulmonary Research Center. The 510(k) number is K884018.

When did LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT receive FDA 510(k) clearance?

LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT received FDA 510(k) clearance on 1989-02-27, under 510(k) number K884018.

Who is the listed applicant for LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT?

The FDA 510(k) record lists Lamelli Pulmonary Research Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT?

The FDA product code for LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT is CAW.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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