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FDA 510(k)

Panther 5

K-Number: K213098 · 2023-07-20

ApplicantOrigin Medical Devices
Decision Date2023-07-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Panther 5 is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medical Devices. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K213098. 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 Panther 5?

Panther 5 is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Origin Medical Devices. The 510(k) number is K213098.

When did Panther 5 receive FDA 510(k) clearance?

Panther 5 received FDA 510(k) clearance on 2023-07-20, under 510(k) number K213098.

Who is the listed applicant for Panther 5?

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

What is the FDA product code for Panther 5?

The FDA product code for Panther 5 is CBK.

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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