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FDA 510(k)

PPG BIOMEDICAL VENTILATOR MODEL IRISA

K-Number: K896442 · 1990-04-16

ApplicantPpg Industries, Inc.
Decision Date1990-04-16
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PPG BIOMEDICAL VENTILATOR MODEL IRISA is the device name listed in this FDA 510(k) record. The listed applicant is Ppg Industries, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K896442. 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 PPG BIOMEDICAL VENTILATOR MODEL IRISA?

PPG BIOMEDICAL VENTILATOR MODEL IRISA is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Ppg Industries, Inc.. The 510(k) number is K896442.

When did PPG BIOMEDICAL VENTILATOR MODEL IRISA receive FDA 510(k) clearance?

PPG BIOMEDICAL VENTILATOR MODEL IRISA received FDA 510(k) clearance on 1990-04-16, under 510(k) number K896442.

Who is the listed applicant for PPG BIOMEDICAL VENTILATOR MODEL IRISA?

The FDA 510(k) record lists Ppg Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PPG BIOMEDICAL VENTILATOR MODEL IRISA?

The FDA product code for PPG BIOMEDICAL VENTILATOR MODEL IRISA is CBK.

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Other records listing Ppg Industries, Inc. as applicant

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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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