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FDA 510(k)

SLENDERTONE SYSTEM ULTRA MODEL E70/X70

K-Number: K100320 · 2010-05-05

ApplicantBio-Medical Research, Ltd.
Decision Date2010-05-05
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE SYSTEM ULTRA MODEL E70/X70 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2010-05-05 under 510(k) number K100320. 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 SLENDERTONE SYSTEM ULTRA MODEL E70/X70?

SLENDERTONE SYSTEM ULTRA MODEL E70/X70 is a medical device that received FDA 510(k) clearance on 2010-05-05. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K100320.

When did SLENDERTONE SYSTEM ULTRA MODEL E70/X70 receive FDA 510(k) clearance?

SLENDERTONE SYSTEM ULTRA MODEL E70/X70 received FDA 510(k) clearance on 2010-05-05, under 510(k) number K100320.

Who is the listed applicant for SLENDERTONE SYSTEM ULTRA MODEL E70/X70?

The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLENDERTONE SYSTEM ULTRA MODEL E70/X70?

The FDA product code for SLENDERTONE SYSTEM ULTRA MODEL E70/X70 is NGX.

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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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