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FDA 510(k)

WEINMANN SOMNOMASK

K-Number: K013738 · 2002-01-22

ApplicantGottlieb Weinmann Geraete Fuer Medizin Und Arbeits
Decision Date2002-01-22
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WEINMANN SOMNOMASK is the device name listed in this FDA 510(k) record. The listed applicant is Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits. It received FDA 510(k) clearance on 2002-01-22 under 510(k) number K013738. 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 WEINMANN SOMNOMASK?

WEINMANN SOMNOMASK is a medical device that received FDA 510(k) clearance on 2002-01-22. The listed applicant is Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits. The 510(k) number is K013738.

When did WEINMANN SOMNOMASK receive FDA 510(k) clearance?

WEINMANN SOMNOMASK received FDA 510(k) clearance on 2002-01-22, under 510(k) number K013738.

Who is the listed applicant for WEINMANN SOMNOMASK?

The FDA 510(k) record lists Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WEINMANN SOMNOMASK?

The FDA product code for WEINMANN SOMNOMASK is BZD.

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Other records listing Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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