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FDA 510(k)

STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964

K-Number: K990574 · 1999-05-24

ApplicantRespironics, Inc.
Decision Date1999-05-24
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1999-05-24 under 510(k) number K990574. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964?

STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 is a medical device that received FDA 510(k) clearance on 1999-05-24. The listed applicant is Respironics, Inc.. The 510(k) number is K990574.

When did STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 receive FDA 510(k) clearance?

STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 received FDA 510(k) clearance on 1999-05-24, under 510(k) number K990574.

Who is the listed applicant for STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964?

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

What is the FDA product code for STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964?

The FDA product code for STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 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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