Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Origin Medical Devices. It received FDA 510(k) clearance on 2023-07-20 under approval 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. It is manufactured by Origin Medical Devices. The 510(k) number is K213098.

When was Panther 5 approved by the FDA?

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

What company makes Panther 5?

Panther 5 is manufactured by Origin Medical Devices.

What is the FDA product code for Panther 5?

The FDA product code for Panther 5 is CBK.

Related Devices (Code: CBK)

K153046HAMILTON-MR1Hamilton Medical AG K152068Astral 100/150Resmed, Ltd. K143035Flight 60 VentilatorFlight Medical Innovations , Ltd. K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP K162738Puritan Bennett 980 Ventilator SystemCovidien K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies

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.

↑