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FDA 510(k)

E100M VENTILATOR (E100M)

K-Number: K972833 · 1999-09-23

ApplicantNewport Medical Instruments, Inc.
Decision Date1999-09-23
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

E100M VENTILATOR (E100M) is the device name listed in this FDA 510(k) record. The listed applicant is Newport Medical Instruments, Inc.. It received FDA 510(k) clearance on 1999-09-23 under 510(k) number K972833. 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 E100M VENTILATOR (E100M)?

E100M VENTILATOR (E100M) is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Newport Medical Instruments, Inc.. The 510(k) number is K972833.

When did E100M VENTILATOR (E100M) receive FDA 510(k) clearance?

E100M VENTILATOR (E100M) received FDA 510(k) clearance on 1999-09-23, under 510(k) number K972833.

Who is the listed applicant for E100M VENTILATOR (E100M)?

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

What is the FDA product code for E100M VENTILATOR (E100M)?

The FDA product code for E100M VENTILATOR (E100M) is CBK.

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Other records listing Newport Medical Instruments, Inc. 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.

K121891NEWPORT AURA VENTILATORK111146NEWPORT HT70 VENTILATORK101803NEWPORT E360 VENTILATORK090888NEWPORT HT70 FAMILY OF VENTILATORSK082724NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEMK061094NEWPORT E500 WAVE VENTILATOR

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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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