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FDA 510(k)

RESPIRONICS MONARCH MINI MASK

K-Number: K945938 · 1996-01-31

ApplicantRespironics, Inc.
Decision Date1996-01-31
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRONICS MONARCH MINI MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1996-01-31 under 510(k) number K945938. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRONICS MONARCH MINI MASK?

RESPIRONICS MONARCH MINI MASK is a medical device that received FDA 510(k) clearance on 1996-01-31. The listed applicant is Respironics, Inc.. The 510(k) number is K945938.

When did RESPIRONICS MONARCH MINI MASK receive FDA 510(k) clearance?

RESPIRONICS MONARCH MINI MASK received FDA 510(k) clearance on 1996-01-31, under 510(k) number K945938.

Who is the listed applicant for RESPIRONICS MONARCH MINI MASK?

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 RESPIRONICS MONARCH MINI MASK?

The FDA product code for RESPIRONICS MONARCH MINI MASK is BZD.

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Other records listing Respironics, Inc. as applicant

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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