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FDA 510(k)

MEDICAL AIR COMPRESSOR, MODEL # 8413419

K-Number: K982789 · 1998-10-29

ApplicantDrager, Inc.
Decision Date1998-10-29
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDICAL AIR COMPRESSOR, MODEL # 8413419 is the device name listed in this FDA 510(k) record. The listed applicant is Drager, Inc.. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K982789. 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, MODEL # 8413419?

MEDICAL AIR COMPRESSOR, MODEL # 8413419 is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Drager, Inc.. The 510(k) number is K982789.

When did MEDICAL AIR COMPRESSOR, MODEL # 8413419 receive FDA 510(k) clearance?

MEDICAL AIR COMPRESSOR, MODEL # 8413419 received FDA 510(k) clearance on 1998-10-29, under 510(k) number K982789.

Who is the listed applicant for MEDICAL AIR COMPRESSOR, MODEL # 8413419?

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

What is the FDA product code for MEDICAL AIR COMPRESSOR, MODEL # 8413419?

The FDA product code for MEDICAL AIR COMPRESSOR, MODEL # 8413419 is BTI.

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Other records listing Drager, 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.

K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 4K984577DRAGER OXYLOG 2000K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900K980642EVITA 4 (8411900)K974176BABYLOG 8000 PLUSK971198BABYTHERM 8004 BABYTHERM 8010

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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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