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FDA 510(k)

SLENDERTONE FLEX, MODEL, 512

K-Number: K010335 · 2001-09-27

ApplicantBio-Medical Research, Ltd.
Decision Date2001-09-27
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE FLEX, MODEL, 512 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 2001-09-27 under 510(k) number K010335. 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 FLEX, MODEL, 512?

SLENDERTONE FLEX, MODEL, 512 is a medical device that received FDA 510(k) clearance on 2001-09-27. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K010335.

When did SLENDERTONE FLEX, MODEL, 512 receive FDA 510(k) clearance?

SLENDERTONE FLEX, MODEL, 512 received FDA 510(k) clearance on 2001-09-27, under 510(k) number K010335.

Who is the listed applicant for SLENDERTONE FLEX, MODEL, 512?

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 FLEX, MODEL, 512?

The FDA product code for SLENDERTONE FLEX, MODEL, 512 is 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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