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FDA 510(k)

IMWXDOP IR

K-Number: K944196 · 1995-05-12

ApplicantImex Medical Systems, Inc.
Decision Date1995-05-12
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMWXDOP IR is the device name listed in this FDA 510(k) record. The listed applicant is Imex Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K944196. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMWXDOP IR?

IMWXDOP IR is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K944196.

When did IMWXDOP IR receive FDA 510(k) clearance?

IMWXDOP IR received FDA 510(k) clearance on 1995-05-12, under 510(k) number K944196.

Who is the listed applicant for IMWXDOP IR?

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

What is the FDA product code for IMWXDOP IR?

The FDA product code for IMWXDOP IR is JAF.

Related Clinical Trials

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Other records listing Imex Medical Systems, 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.

K973556IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000K973562IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100K973336IMEX STETHODOPK970156IMEX FUTURALDOP PROK942243IMEX 8000 PERSONAL CASCULAR LABK942441IMEXDOP CT+

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Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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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