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FDA 510(k)

ASCENDING VENTILATOR BELLOWS

K-Number: K874371 · 1987-12-11

ApplicantDraeger Medical, Inc.
Decision Date1987-12-11
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ASCENDING VENTILATOR BELLOWS is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 1987-12-11 under 510(k) number K874371. 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 ASCENDING VENTILATOR BELLOWS?

ASCENDING VENTILATOR BELLOWS is a medical device that received FDA 510(k) clearance on 1987-12-11. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K874371.

When did ASCENDING VENTILATOR BELLOWS receive FDA 510(k) clearance?

ASCENDING VENTILATOR BELLOWS received FDA 510(k) clearance on 1987-12-11, under 510(k) number K874371.

Who is the listed applicant for ASCENDING VENTILATOR BELLOWS?

The FDA 510(k) record lists Draeger Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASCENDING VENTILATOR BELLOWS?

The FDA product code for ASCENDING VENTILATOR BELLOWS is CBK.

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Other records listing Draeger Medical, Inc. 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.

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP 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.

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