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FDA 510(k)

SOYALA GEL VENTED

K-Number: K081014 · 2008-05-09

ApplicantWeinmann Gerate Fur Medizin GmbH + Co. KG
Decision Date2008-05-09
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOYALA GEL VENTED 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 2008-05-09 under 510(k) number K081014. 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 GEL VENTED?

SOYALA GEL VENTED is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Weinmann Gerate Fur Medizin GmbH + Co. KG. The 510(k) number is K081014.

When did SOYALA GEL VENTED receive FDA 510(k) clearance?

SOYALA GEL VENTED received FDA 510(k) clearance on 2008-05-09, under 510(k) number K081014.

Who is the listed applicant for SOYALA GEL VENTED?

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 GEL VENTED?

The FDA product code for SOYALA GEL VENTED is BZD.

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

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Related Devices (Code: BZD)

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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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