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FDA 510(k)

MODEL #5000 PULMO PLUS

K-Number: K946039 · 1995-06-16

ApplicantInternational Medical Systems
Decision Date1995-06-16
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL #5000 PULMO PLUS is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Systems. It received FDA 510(k) clearance on 1995-06-16 under 510(k) number K946039. 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 MODEL #5000 PULMO PLUS?

MODEL #5000 PULMO PLUS is a medical device that received FDA 510(k) clearance on 1995-06-16. The listed applicant is International Medical Systems. The 510(k) number is K946039.

When did MODEL #5000 PULMO PLUS receive FDA 510(k) clearance?

MODEL #5000 PULMO PLUS received FDA 510(k) clearance on 1995-06-16, under 510(k) number K946039.

Who is the listed applicant for MODEL #5000 PULMO PLUS?

The FDA 510(k) record lists International Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL #5000 PULMO PLUS?

The FDA product code for MODEL #5000 PULMO PLUS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing International Medical Systems 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.

K990515MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM

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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