FDA 510(k)

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS

K-Number: K081743 · 2008-09-22

Decision Date2008-09-22

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical AG & Co. KG. It received FDA 510(k) clearance on 2008-09-22 under 510(k) number K081743. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS?

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS is a medical device that received FDA 510(k) clearance on 2008-09-22. The listed applicant is Draeger Medical AG & Co. KG. The 510(k) number is K081743.

When did CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS receive FDA 510(k) clearance?

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS received FDA 510(k) clearance on 2008-09-22, under 510(k) number K081743.

Who is the listed applicant for CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS?

The FDA 510(k) record lists Draeger Medical AG & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS?

The FDA product code for CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS is CBK.

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Other records listing Draeger Medical AG & Co. KG as applicant

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Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics 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.