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FDA 510(k)

INFANT VENTILATOR

K-Number: K911450 · 1991-06-18

ApplicantPreemicare Corp.
Decision Date1991-06-18
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Preemicare Corp.. It received FDA 510(k) clearance on 1991-06-18 under 510(k) number K911450. 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 INFANT VENTILATOR?

INFANT VENTILATOR is a medical device that received FDA 510(k) clearance on 1991-06-18. The listed applicant is Preemicare Corp.. The 510(k) number is K911450.

When did INFANT VENTILATOR receive FDA 510(k) clearance?

INFANT VENTILATOR received FDA 510(k) clearance on 1991-06-18, under 510(k) number K911450.

Who is the listed applicant for INFANT VENTILATOR?

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

What is the FDA product code for INFANT VENTILATOR?

The FDA product code for INFANT VENTILATOR is CBK.

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Other records listing Preemicare 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.

K896375PREEMICARE NEBUTECH NEBULIZER SYSTEMK900735MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATORK893622PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.K893624PREEMICARE MODEL 2500 TRANSPORT WARMERK891674NEONATAL ENVIRONMENTAL MONITOR, MODEL 275K885350PREEMICARE SERIES 2000 INFANT WARMER

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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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