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FDA 510(k)

CPU 1100 VENTILATOR

K-Number: K880054 · 1988-04-14

ApplicantOhmeda Medical
Decision Date1988-04-14
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPU 1100 VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1988-04-14 under 510(k) number K880054. 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 CPU 1100 VENTILATOR?

CPU 1100 VENTILATOR is a medical device that received FDA 510(k) clearance on 1988-04-14. The listed applicant is Ohmeda Medical. The 510(k) number is K880054.

When did CPU 1100 VENTILATOR receive FDA 510(k) clearance?

CPU 1100 VENTILATOR received FDA 510(k) clearance on 1988-04-14, under 510(k) number K880054.

Who is the listed applicant for CPU 1100 VENTILATOR?

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

What is the FDA product code for CPU 1100 VENTILATOR?

The FDA product code for CPU 1100 VENTILATOR is CBK.

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Other records listing Ohmeda Medical 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.

K123309GIRAFFE AND PANDA WARMERSK101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA 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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