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FDA 510(k)

BELTBEAT WF-400

K-Number: K083715 · 2009-09-15

ApplicantBonus Communicaciones Srl
Decision Date2009-09-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BELTBEAT WF-400 is the device name listed in this FDA 510(k) record. The listed applicant is Bonus Communicaciones Srl. It received FDA 510(k) clearance on 2009-09-15 under 510(k) number K083715. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELTBEAT WF-400?

BELTBEAT WF-400 is a medical device that received FDA 510(k) clearance on 2009-09-15. The listed applicant is Bonus Communicaciones Srl. The 510(k) number is K083715.

When did BELTBEAT WF-400 receive FDA 510(k) clearance?

BELTBEAT WF-400 received FDA 510(k) clearance on 2009-09-15, under 510(k) number K083715.

Who is the listed applicant for BELTBEAT WF-400?

The FDA 510(k) record lists Bonus Communicaciones Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BELTBEAT WF-400?

The FDA product code for BELTBEAT WF-400 is DPS.

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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.

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