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FDA 510(k)

NARKOMED AV2+ ANESTHESIA VENTILATOR

K-Number: K953228 · 1996-03-01

ApplicantDraeger Medical, Inc.
Decision Date1996-03-01
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

NARKOMED AV2+ ANESTHESIA VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 1996-03-01 under 510(k) number K953228. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the NARKOMED AV2+ ANESTHESIA VENTILATOR?

NARKOMED AV2+ ANESTHESIA VENTILATOR is a medical device that received FDA 510(k) clearance on 1996-03-01. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K953228.

When did NARKOMED AV2+ ANESTHESIA VENTILATOR receive FDA 510(k) clearance?

NARKOMED AV2+ ANESTHESIA VENTILATOR received FDA 510(k) clearance on 1996-03-01, under 510(k) number K953228.

Who is the listed applicant for NARKOMED AV2+ ANESTHESIA VENTILATOR?

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

What is the FDA product code for NARKOMED AV2+ ANESTHESIA VENTILATOR?

The FDA product code for NARKOMED AV2+ ANESTHESIA VENTILATOR is CBK.

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Other records listing Draeger Medical, 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.

K042607PRIMUS USK042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMK042276D-VAPORK042086FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK040847MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR

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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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