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FDA 510(k)

POWERTONE, MODEL PT-11

K-Number: K062439 · 2007-01-08

ApplicantJohari Digital Healthcare , Ltd.
Decision Date2007-01-08
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POWERTONE, MODEL PT-11 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 2007-01-08 under 510(k) number K062439. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERTONE, MODEL PT-11?

POWERTONE, MODEL PT-11 is a medical device that received FDA 510(k) clearance on 2007-01-08. The listed applicant is Johari Digital Healthcare , Ltd.. The 510(k) number is K062439.

When did POWERTONE, MODEL PT-11 receive FDA 510(k) clearance?

POWERTONE, MODEL PT-11 received FDA 510(k) clearance on 2007-01-08, under 510(k) number K062439.

Who is the listed applicant for POWERTONE, MODEL PT-11?

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 POWERTONE, MODEL PT-11?

The FDA product code for POWERTONE, MODEL PT-11 is NGX.

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Other records listing Johari Digital Healthcare , Ltd. as applicant

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Related Devices (Code: NGX)

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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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