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FDA 510(k)

OXICOM CONTROL

K-Number: K053327 · 2006-01-26

ApplicantBionostics, Inc.
Decision Date2006-01-26
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OXICOM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K053327. 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 OXICOM CONTROL?

OXICOM CONTROL is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Bionostics, Inc.. The 510(k) number is K053327.

When did OXICOM CONTROL receive FDA 510(k) clearance?

OXICOM CONTROL received FDA 510(k) clearance on 2006-01-26, under 510(k) number K053327.

Who is the listed applicant for OXICOM CONTROL?

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 OXICOM CONTROL?

The FDA product code for OXICOM CONTROL 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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