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FDA 510(k)

BEAR 2 ADULT VOL. VENTILATOR

K-Number: K802118 · 1980-10-03

ApplicantBourns Medical Systems, Inc.
Decision Date1980-10-03
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BEAR 2 ADULT VOL. VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bourns Medical Systems, Inc.. It received FDA 510(k) clearance on 1980-10-03 under 510(k) number K802118. 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 BEAR 2 ADULT VOL. VENTILATOR?

BEAR 2 ADULT VOL. VENTILATOR is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Bourns Medical Systems, Inc.. The 510(k) number is K802118.

When did BEAR 2 ADULT VOL. VENTILATOR receive FDA 510(k) clearance?

BEAR 2 ADULT VOL. VENTILATOR received FDA 510(k) clearance on 1980-10-03, under 510(k) number K802118.

Who is the listed applicant for BEAR 2 ADULT VOL. VENTILATOR?

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

What is the FDA product code for BEAR 2 ADULT VOL. VENTILATOR?

The FDA product code for BEAR 2 ADULT VOL. VENTILATOR is CBK.

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Other records listing Bourns Medical Systems, 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.

K802051NEWBOURNS INFANT VENTILATORK801697MODEL BP-200 INFANT PRESSURE VENTILATORK791186MODEL BP-2000 TIME-CYCLED VENTILATORK790199VENTILATOR MODEL BV-300 INFANTK781760HUMIDIFIERS, MODEL:LS-420 AND LS-460K781485PATIENT CIRCUIT MANIFOLD

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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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