Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOYALA FULL FACE MASK

K-Number: K061653 · 2006-11-09

ApplicantWeinmann Gerate Fur Medizin GmbH + Co. KG
Decision Date2006-11-09
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOYALA 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 2006-11-09 under 510(k) number K061653. 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 FULL FACE MASK?

SOYALA FULL FACE MASK is a medical device that received FDA 510(k) clearance on 2006-11-09. The listed applicant is Weinmann Gerate Fur Medizin GmbH + Co. KG. The 510(k) number is K061653.

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

SOYALA FULL FACE MASK received FDA 510(k) clearance on 2006-11-09, under 510(k) number K061653.

Who is the listed applicant for SOYALA 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 FULL FACE MASK?

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K112167SOYALA SILKGEL FULL FACE MASKK110884EASYFIT SILKGEL NASAL MASKK102515NP15K081014SOYALA GEL VENTEDK073673SOYALA FULL FACE MASK GEL VENTEDK072009WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340

View all 9 devices →

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.

↑