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FDA 510(k)

CEFALY Connected - OTC, CEFALY Connected - Rx

K-Number: K234029 · 2024-07-18

ApplicantCefaly Technology
Decision Date2024-07-18
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CEFALY Connected - OTC, CEFALY Connected - Rx is the device name listed in this FDA 510(k) record. The listed applicant is Cefaly Technology. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K234029. 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 Connected - OTC, CEFALY Connected - Rx?

CEFALY Connected - OTC, CEFALY Connected - Rx is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Cefaly Technology. The 510(k) number is K234029.

When did CEFALY Connected - OTC, CEFALY Connected - Rx receive FDA 510(k) clearance?

CEFALY Connected - OTC, CEFALY Connected - Rx received FDA 510(k) clearance on 2024-07-18, under 510(k) number K234029.

Who is the listed applicant for CEFALY Connected - OTC, CEFALY Connected - Rx?

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

What is the FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx?

The FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx is PCC.

Other records listing Cefaly Technology as applicant

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.

K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxK201895Cefaly DualK173006Cefaly DualK171446Cefaly AcuteK160237Cefaly

Related Devices (Code: PCC)

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.

K254216Enso for MigraineHinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K232749DOOPANGYbrain, Inc.K233751Milieve (YPS-301BD)Soterix Medical, Inc.K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxCefaly Technology

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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