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FDA 510(k)

8400ST VOLUME VENTILATOR

K-Number: K894322 · 1990-01-29

ApplicantBird Products Corp.
Decision Date1990-01-29
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

8400ST 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 1990-01-29 under 510(k) number K894322. 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 8400ST VOLUME VENTILATOR?

8400ST VOLUME VENTILATOR is a medical device that received FDA 510(k) clearance on 1990-01-29. The listed applicant is Bird Products Corp.. The 510(k) number is K894322.

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

8400ST VOLUME VENTILATOR received FDA 510(k) clearance on 1990-01-29, under 510(k) number K894322.

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

The FDA product code for 8400ST 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 VENTILATORK020730ORION NASAL CPAP SYSTEMK013642AVEAK020746BIRD 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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