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)

Claritag

K-Number: K190747 · 2019-10-31

ApplicantDgi Technologies
Decision Date2019-10-31
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Claritag is a medical device manufactured by Dgi Technologies. It received FDA 510(k) clearance on 2019-10-31 under approval number K190747. 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 Claritag?

Claritag is a medical device that received FDA 510(k) clearance on 2019-10-31. It is manufactured by Dgi Technologies. The 510(k) number is K190747.

When was Claritag approved by the FDA?

Claritag received FDA 510(k) clearance on 2019-10-31, under approval number K190747.

What company makes Claritag?

Claritag is manufactured by Dgi Technologies.

What is the FDA product code for Claritag?

The FDA product code for Claritag is GEH.

Other Devices by Dgi Technologies

K222356Claritag Advanced

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.

↑