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FDA 510(k)

GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

K-Number: K091833 · 2009-10-16

ApplicantGemore Technology Co, Ltd.
Decision Date2009-10-16
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. is the device name listed in this FDA 510(k) record. The listed applicant is Gemore Technology Co, Ltd.. It received FDA 510(k) clearance on 2009-10-16 under 510(k) number K091833. 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 GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.?

GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. is a medical device that received FDA 510(k) clearance on 2009-10-16. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K091833.

When did GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. receive FDA 510(k) clearance?

GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. received FDA 510(k) clearance on 2009-10-16, under 510(k) number K091833.

Who is the listed applicant for GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.?

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

What is the FDA product code for GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.?

The FDA product code for GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. is NGX.

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Other records listing Gemore Technology Co, 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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