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FDA 510(k)

PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.

K-Number: K893622 · 1990-01-03

ApplicantPreemicare Corp.
Decision Date1990-01-03
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. is the device name listed in this FDA 510(k) record. The listed applicant is Preemicare Corp.. It received FDA 510(k) clearance on 1990-01-03 under 510(k) number K893622. 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 PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.?

PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. is a medical device that received FDA 510(k) clearance on 1990-01-03. The listed applicant is Preemicare Corp.. The 510(k) number is K893622.

When did PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. receive FDA 510(k) clearance?

PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. received FDA 510(k) clearance on 1990-01-03, under 510(k) number K893622.

Who is the listed applicant for PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.?

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 PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.?

The FDA product code for PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. 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.

K911450INFANT VENTILATORK896375PREEMICARE NEBUTECH NEBULIZER SYSTEMK900735MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATORK893624PREEMICARE 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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