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FDA 510(k)

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C

K-Number: K090052 · 2009-05-29

ApplicantJohari Digital Healthcare , Ltd.
Decision Date2009-05-29
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C is the device name listed in this FDA 510(k) record. The listed applicant is Johari Digital Healthcare , Ltd.. It received FDA 510(k) clearance on 2009-05-29 under 510(k) number K090052. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C?

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C is a medical device that received FDA 510(k) clearance on 2009-05-29. The listed applicant is Johari Digital Healthcare , Ltd.. The 510(k) number is K090052.

When did CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C receive FDA 510(k) clearance?

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C received FDA 510(k) clearance on 2009-05-29, under 510(k) number K090052.

Who is the listed applicant for CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C?

The FDA 510(k) record lists Johari Digital Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C?

The FDA product code for CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C is QJQ.

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Other records listing Johari Digital Healthcare , Ltd. as applicant

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Related Devices (Code: QJQ)

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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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