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FDA 510(k)

VENTILATOR MODEL BV-300 INFANT

K-Number: K790199 · 1979-04-13

ApplicantBourns Medical Systems, Inc.
Decision Date1979-04-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTILATOR MODEL BV-300 INFANT 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 1979-04-13 under 510(k) number K790199. 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 VENTILATOR MODEL BV-300 INFANT?

VENTILATOR MODEL BV-300 INFANT is a medical device that received FDA 510(k) clearance on 1979-04-13. The listed applicant is Bourns Medical Systems, Inc.. The 510(k) number is K790199.

When did VENTILATOR MODEL BV-300 INFANT receive FDA 510(k) clearance?

VENTILATOR MODEL BV-300 INFANT received FDA 510(k) clearance on 1979-04-13, under 510(k) number K790199.

Who is the listed applicant for VENTILATOR MODEL BV-300 INFANT?

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 VENTILATOR MODEL BV-300 INFANT?

The FDA product code for VENTILATOR MODEL BV-300 INFANT 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.

K802118BEAR 2 ADULT VOL. VENTILATORK802051NEWBOURNS INFANT VENTILATORK801697MODEL BP-200 INFANT PRESSURE VENTILATORK791186MODEL BP-2000 TIME-CYCLED VENTILATORK781760HUMIDIFIERS, 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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