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FDA 510(k)

MEDICAL AIR COMPRESSOR

K-Number: K113338 · 2012-08-10

ApplicantOricare, Inc.
Decision Date2012-08-10
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDICAL AIR COMPRESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Oricare, Inc.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K113338. The device is classified under product code BTI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAL AIR COMPRESSOR?

MEDICAL AIR COMPRESSOR is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Oricare, Inc.. The 510(k) number is K113338.

When did MEDICAL AIR COMPRESSOR receive FDA 510(k) clearance?

MEDICAL AIR COMPRESSOR received FDA 510(k) clearance on 2012-08-10, under 510(k) number K113338.

Who is the listed applicant for MEDICAL AIR COMPRESSOR?

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

What is the FDA product code for MEDICAL AIR COMPRESSOR?

The FDA product code for MEDICAL AIR COMPRESSOR is BTI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Oricare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120931CRITICAL CARE VENTILATORK122875ORICARE L2700

Related Devices (Code: BTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131881OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.K091871DK50 DSEkom S.R.O.K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DMEkom S.R.O.K051691MINIMATE COMPRESSORPrecision Medical, Inc.K041781VENTILAIR II MEDICAL AIR COMPRESSORHamilton Medical AG

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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