FDA 510(k)

OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067

K-Number: K992670 · 1999-09-17

ApplicantInstrumentation Industries, Inc.

Decision Date1999-09-17

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Industries, Inc.. It received FDA 510(k) clearance on 1999-09-17 under 510(k) number K992670. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067?

OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K992670.

When did OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 receive FDA 510(k) clearance?

OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 received FDA 510(k) clearance on 1999-09-17, under 510(k) number K992670.

Who is the listed applicant for OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067?

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

What is the FDA product code for OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067?

The FDA product code for OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 is CBK.

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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.