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FDA 510(k)

OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION

K-Number: K091914 · 2009-11-06

ApplicantBionostics, Inc.
Decision Date2009-11-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2009-11-06 under 510(k) number K091914. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION?

OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 2009-11-06. The listed applicant is Bionostics, Inc.. The 510(k) number is K091914.

When did OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION receive FDA 510(k) clearance?

OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION received FDA 510(k) clearance on 2009-11-06, under 510(k) number K091914.

Who is the listed applicant for OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION?

The FDA 510(k) record lists Bionostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION?

The FDA product code for OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION is JJX.

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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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