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FDA 510(k)

EVITA 4

K-Number: K961687 · 1996-12-13

ApplicantDrager, Inc.
Decision Date1996-12-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

EVITA 4 is the device name listed in this FDA 510(k) record. The listed applicant is Drager, Inc.. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K961687. 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 EVITA 4?

EVITA 4 is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Drager, Inc.. The 510(k) number is K961687.

When did EVITA 4 receive FDA 510(k) clearance?

EVITA 4 received FDA 510(k) clearance on 1996-12-13, under 510(k) number K961687.

Who is the listed applicant for EVITA 4?

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 EVITA 4?

The FDA product code for EVITA 4 is CBK.

Related Clinical Trials

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.

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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 2000K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419K980642EVITA 4 (8411900)K974176BABYLOG 8000 PLUS

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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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