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FDA 510(k)

SG-066 OXYGEN ENRICHMENT KIT

K-Number: K860077 · 1986-02-18

ApplicantInstrumentation Industries, Inc.
Decision Date1986-02-18
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SG-066 OXYGEN ENRICHMENT KIT 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 1986-02-18 under 510(k) number K860077. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SG-066 OXYGEN ENRICHMENT KIT?

SG-066 OXYGEN ENRICHMENT KIT is a medical device that received FDA 510(k) clearance on 1986-02-18. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K860077.

When did SG-066 OXYGEN ENRICHMENT KIT receive FDA 510(k) clearance?

SG-066 OXYGEN ENRICHMENT KIT received FDA 510(k) clearance on 1986-02-18, under 510(k) number K860077.

Who is the listed applicant for SG-066 OXYGEN ENRICHMENT KIT?

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 SG-066 OXYGEN ENRICHMENT KIT?

The FDA product code for SG-066 OXYGEN ENRICHMENT KIT is BTL.

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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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