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FDA 510(k)

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E

K-Number: K023354 · 2003-09-05

ApplicantSiemens Elema AB
Decision Date2003-09-05
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 2003-09-05 under 510(k) number K023354. 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 COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E?

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E is a medical device that received FDA 510(k) clearance on 2003-09-05. The listed applicant is Siemens Elema AB. The 510(k) number is K023354.

When did COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E receive FDA 510(k) clearance?

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E received FDA 510(k) clearance on 2003-09-05, under 510(k) number K023354.

Who is the listed applicant for COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E?

The FDA 510(k) record lists Siemens Elema AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E?

The FDA product code for COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E is BTI.

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Other records listing Siemens Elema AB as applicant

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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.K113338MEDICAL AIR COMPRESSOROricare, Inc.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.

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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