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FDA 510(k)

Cefaly Dual

K-Number: K201895 · 2020-09-29

ApplicantCefaly Technology
Decision Date2020-09-29
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cefaly Dual is a medical device manufactured by Cefaly Technology. It received FDA 510(k) clearance on 2020-09-29 under approval number K201895. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cefaly Dual?

Cefaly Dual is a medical device that received FDA 510(k) clearance on 2020-09-29. It is manufactured by Cefaly Technology. The 510(k) number is K201895.

When was Cefaly Dual approved by the FDA?

Cefaly Dual received FDA 510(k) clearance on 2020-09-29, under approval number K201895.

What company makes Cefaly Dual?

Cefaly Dual is manufactured by Cefaly Technology.

What is the FDA product code for Cefaly Dual?

The FDA product code for Cefaly Dual is PCC.

Other Devices by Cefaly Technology

K160237Cefaly K173006Cefaly Dual K171446Cefaly Acute K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx K234029CEFALY Connected - OTC, CEFALY Connected - Rx

Related Devices (Code: PCC)

K160237CefalyCefaly Technology K173006Cefaly DualCefaly Technology K171446Cefaly AcuteCefaly Technology K172450TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd. K192773ALLIVENu Eyne Co., Ltd. K212106RelivionNeurolief , Ltd.

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.

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