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FDA 510(k)

ULTIMA SMARTBELT, MODEL 0560

K-Number: K001743 · 2000-08-25

ApplicantBraebon Medical Corp.
Decision Date2000-08-25
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTIMA SMARTBELT, MODEL 0560 is the device name listed in this FDA 510(k) record. The listed applicant is Braebon Medical Corp.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K001743. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMA SMARTBELT, MODEL 0560?

ULTIMA SMARTBELT, MODEL 0560 is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Braebon Medical Corp.. The 510(k) number is K001743.

When did ULTIMA SMARTBELT, MODEL 0560 receive FDA 510(k) clearance?

ULTIMA SMARTBELT, MODEL 0560 received FDA 510(k) clearance on 2000-08-25, under 510(k) number K001743.

Who is the listed applicant for ULTIMA SMARTBELT, MODEL 0560?

The FDA 510(k) record lists Braebon Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMA SMARTBELT, MODEL 0560?

The FDA product code for ULTIMA SMARTBELT, MODEL 0560 is BZQ.

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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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