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FDA 510(k)

SIMPLE T NASAL MASK

K-Number: K121631 · 2012-10-05

ApplicantRespironics, Inc.
Decision Date2012-10-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIMPLE T NASAL 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 2012-10-05 under 510(k) number K121631. 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 SIMPLE T NASAL MASK?

SIMPLE T NASAL MASK is a medical device that received FDA 510(k) clearance on 2012-10-05. The listed applicant is Respironics, Inc.. The 510(k) number is K121631.

When did SIMPLE T NASAL MASK receive FDA 510(k) clearance?

SIMPLE T NASAL MASK received FDA 510(k) clearance on 2012-10-05, under 510(k) number K121631.

Who is the listed applicant for SIMPLE T NASAL 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 SIMPLE T NASAL MASK?

The FDA product code for SIMPLE T NASAL 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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