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)

Frozen C

K-Number: K182392 · 2018-10-30

ApplicantB.M. Tech. Worldwide Co., Ltd.
Decision Date2018-10-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Frozen C is a medical device manufactured by B.M. Tech. Worldwide Co., Ltd.. It received FDA 510(k) clearance on 2018-10-30 under approval number K182392. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Frozen C?

Frozen C is a medical device that received FDA 510(k) clearance on 2018-10-30. It is manufactured by B.M. Tech. Worldwide Co., Ltd.. The 510(k) number is K182392.

When was Frozen C approved by the FDA?

Frozen C received FDA 510(k) clearance on 2018-10-30, under approval number K182392.

What company makes Frozen C?

Frozen C is manufactured by B.M. Tech. Worldwide Co., Ltd..

What is the FDA product code for Frozen C?

The FDA product code for Frozen C is GEH.

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

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.

↑