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FDA 510(k)

SOYALA SILKGEL FULL FACE MASK

K-Number: K112167 · 2011-11-16

ApplicantWeinmann Gerate Fur Medizin GmbH + Co. KG
Decision Date2011-11-16
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOYALA SILKGEL FULL FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Weinmann Gerate Fur Medizin GmbH + Co. KG. It received FDA 510(k) clearance on 2011-11-16 under 510(k) number K112167. 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 SOYALA SILKGEL FULL FACE MASK?

SOYALA SILKGEL FULL FACE MASK is a medical device that received FDA 510(k) clearance on 2011-11-16. The listed applicant is Weinmann Gerate Fur Medizin GmbH + Co. KG. The 510(k) number is K112167.

When did SOYALA SILKGEL FULL FACE MASK receive FDA 510(k) clearance?

SOYALA SILKGEL FULL FACE MASK received FDA 510(k) clearance on 2011-11-16, under 510(k) number K112167.

Who is the listed applicant for SOYALA SILKGEL FULL FACE MASK?

The FDA 510(k) record lists Weinmann Gerate Fur Medizin GmbH + Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOYALA SILKGEL FULL FACE MASK?

The FDA product code for SOYALA SILKGEL FULL FACE MASK is BZD.

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Other records listing Weinmann Gerate Fur Medizin GmbH + Co. KG as applicant

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.

K110884EASYFIT SILKGEL NASAL MASKK102515NP15K081014SOYALA GEL VENTEDK073673SOYALA FULL FACE MASK GEL VENTEDK072009WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340K071163WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603

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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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