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FDA 510(k)

GOODKNIGHT H20, MODEL M-114600-00

K-Number: K042184 · 2005-01-10

ApplicantMallinckrodt Developpement France
Decision Date2005-01-10
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GOODKNIGHT H20, MODEL M-114600-00 is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Developpement France. It received FDA 510(k) clearance on 2005-01-10 under 510(k) number K042184. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOODKNIGHT H20, MODEL M-114600-00?

GOODKNIGHT H20, MODEL M-114600-00 is a medical device that received FDA 510(k) clearance on 2005-01-10. The listed applicant is Mallinckrodt Developpement France. The 510(k) number is K042184.

When did GOODKNIGHT H20, MODEL M-114600-00 receive FDA 510(k) clearance?

GOODKNIGHT H20, MODEL M-114600-00 received FDA 510(k) clearance on 2005-01-10, under 510(k) number K042184.

Who is the listed applicant for GOODKNIGHT H20, MODEL M-114600-00?

The FDA 510(k) record lists Mallinckrodt Developpement France as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOODKNIGHT H20, MODEL M-114600-00?

The FDA product code for GOODKNIGHT H20, MODEL M-114600-00 is BTT.

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Other records listing Mallinckrodt Developpement France as applicant

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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Related Devices (Code: BTT)

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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