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FDA 510(k)

NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900

K-Number: K983219 · 1998-12-07

ApplicantDrager, Inc.
Decision Date1998-12-07
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 is the device name listed in this FDA 510(k) record. The listed applicant is Drager, Inc.. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K983219. 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 NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900?

NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Drager, Inc.. The 510(k) number is K983219.

When did NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 receive FDA 510(k) clearance?

NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983219.

Who is the listed applicant for NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900?

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

What is the FDA product code for NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900?

The FDA product code for NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 is CBK.

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Other records listing Drager, 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.

K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 4K984577DRAGER OXYLOG 2000K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419K980642EVITA 4 (8411900)K974176BABYLOG 8000 PLUSK971198BABYTHERM 8004 BABYTHERM 8010

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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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