FDA 510(k)

BEMER Classic Set, BEMER Pro-Set

K-Number: K151834 · 2017-02-22

Decision Date2017-02-22

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

BEMER Classic Set, BEMER Pro-Set is a medical device manufactured by Bemer Int AG. It received FDA 510(k) clearance on 2017-02-22 under approval number K151834. 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 BEMER Classic Set, BEMER Pro-Set?

BEMER Classic Set, BEMER Pro-Set is a medical device that received FDA 510(k) clearance on 2017-02-22. It is manufactured by Bemer Int AG. The 510(k) number is K151834.

When was BEMER Classic Set, BEMER Pro-Set approved by the FDA?

BEMER Classic Set, BEMER Pro-Set received FDA 510(k) clearance on 2017-02-22, under approval number K151834.

What company makes BEMER Classic Set, BEMER Pro-Set?

BEMER Classic Set, BEMER Pro-Set is manufactured by Bemer Int AG.

What is the FDA product code for BEMER Classic Set, BEMER Pro-Set?

The FDA product code for BEMER Classic Set, BEMER Pro-Set is NGX.

Other Devices by Bemer Int AG

K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set K223919B.Light Clear Evo and B.Light Restore Evo K231368Bemer Therapy System Evo

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.