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FDA 510(k)

ACUTE CARE FACE MASK, MODEL RT040

K-Number: K060044 · 2006-04-06

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2006-04-06
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACUTE CARE FACE MASK, MODEL RT040 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2006-04-06 under 510(k) number K060044. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUTE CARE FACE MASK, MODEL RT040?

ACUTE CARE FACE MASK, MODEL RT040 is a medical device that received FDA 510(k) clearance on 2006-04-06. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K060044.

When did ACUTE CARE FACE MASK, MODEL RT040 receive FDA 510(k) clearance?

ACUTE CARE FACE MASK, MODEL RT040 received FDA 510(k) clearance on 2006-04-06, under 510(k) number K060044.

Who is the listed applicant for ACUTE CARE FACE MASK, MODEL RT040?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUTE CARE FACE MASK, MODEL RT040?

The FDA product code for ACUTE CARE FACE MASK, MODEL RT040 is MNT.

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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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