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FDA 510(k)

BIRD 8400ST ADULT VOLUME VENTILATOR

K-Number: K921387 · 1993-03-11

ApplicantBird Products Corp.
Decision Date1993-03-11
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIRD 8400ST ADULT VOLUME VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bird Products Corp.. It received FDA 510(k) clearance on 1993-03-11 under 510(k) number K921387. 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 BIRD 8400ST ADULT VOLUME VENTILATOR?

BIRD 8400ST ADULT VOLUME VENTILATOR is a medical device that received FDA 510(k) clearance on 1993-03-11. The listed applicant is Bird Products Corp.. The 510(k) number is K921387.

When did BIRD 8400ST ADULT VOLUME VENTILATOR receive FDA 510(k) clearance?

BIRD 8400ST ADULT VOLUME VENTILATOR received FDA 510(k) clearance on 1993-03-11, under 510(k) number K921387.

Who is the listed applicant for BIRD 8400ST ADULT VOLUME VENTILATOR?

The FDA 510(k) record lists Bird Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIRD 8400ST ADULT VOLUME VENTILATOR?

The FDA product code for BIRD 8400ST ADULT VOLUME VENTILATOR is CBK.

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Other records listing Bird Products Corp. 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.

K032451BIRD TBIRD VELA VENTILATORK022674BIRD AVEA VENTILATORK013642AVEAK020730ORION NASAL CPAP SYSTEMK020746BIRD TBIRD VELA VENTILATORK003770BIRD TBIRD LEGACY VENTILATOR

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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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