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FDA 510(k)

Bellavista

K-Number: K183364 · 2019-09-13

ApplicantImtmedical AG
Decision Date2019-09-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Bellavista is the device name listed in this FDA 510(k) record. The listed applicant is Imtmedical AG. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K183364. 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?

Bellavista is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Imtmedical AG. The 510(k) number is K183364.

When did Bellavista receive FDA 510(k) clearance?

Bellavista received FDA 510(k) clearance on 2019-09-13, under 510(k) number K183364.

Who is the listed applicant for Bellavista?

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?

The FDA product code for Bellavista 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.

K163127bellavista 1000

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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