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FDA 510(k)

OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)

K-Number: K001121 · 2001-11-29

ApplicantEngineered Medical Technology, Inc.
Decision Date2001-11-29
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Technology, Inc.. It received FDA 510(k) clearance on 2001-11-29 under 510(k) number K001121. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)?

OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) is a medical device that received FDA 510(k) clearance on 2001-11-29. The listed applicant is Engineered Medical Technology, Inc.. The 510(k) number is K001121.

When did OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) receive FDA 510(k) clearance?

OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) received FDA 510(k) clearance on 2001-11-29, under 510(k) number K001121.

Who is the listed applicant for OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)?

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

What is the FDA product code for OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)?

The FDA product code for OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) is CBF.

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Related Devices (Code: CBF)

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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.

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