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FDA 510(k)

bellavista 1000

K-Number: K163127 · 2017-07-31

ApplicantImtmedical AG
Decision Date2017-07-31
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

bellavista 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Imtmedical AG. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K163127. 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 bellavista 1000?

bellavista 1000 is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Imtmedical AG. The 510(k) number is K163127.

When did bellavista 1000 receive FDA 510(k) clearance?

bellavista 1000 received FDA 510(k) clearance on 2017-07-31, under 510(k) number K163127.

Who is the listed applicant for bellavista 1000?

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

What is the FDA product code for bellavista 1000?

The FDA product code for bellavista 1000 is CBK.

Other records listing Imtmedical AG 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.

K183364Bellavista

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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