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FDA 510(k)

CRITICAL CARE VENTILATOR 2

K-Number: K772065 · 1977-11-28

ApplicantOhio Medical Products
Decision Date1977-11-28
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CRITICAL CARE VENTILATOR 2 is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Products. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772065. 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 CRITICAL CARE VENTILATOR 2?

CRITICAL CARE VENTILATOR 2 is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Ohio Medical Products. The 510(k) number is K772065.

When did CRITICAL CARE VENTILATOR 2 receive FDA 510(k) clearance?

CRITICAL CARE VENTILATOR 2 received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772065.

Who is the listed applicant for CRITICAL CARE VENTILATOR 2?

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

What is the FDA product code for CRITICAL CARE VENTILATOR 2?

The FDA product code for CRITICAL CARE VENTILATOR 2 is CBK.

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Other records listing Ohio Medical Products 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.

K841733OHIO WASTE GAS SCAVENGING RESERVOIRK842003OHIO WASTE GAS SCAVENGING INTERFACEK840356OHIO UNITROL II ANESTHESIA GAS MACHINEK841274BAG-TO-VENTILATOR SELECTOR VALVEK840967OHIO HEAT REFLECTING PATCHK840857OHIO 3000 INFANT WARMER SYSTEM

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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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