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FDA 510(k)

IMEX FUTURALDOP PRO

K-Number: K970156 · 1997-04-04

ApplicantImex Medical Systems, Inc.
Decision Date1997-04-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMEX FUTURALDOP PRO 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 1997-04-04 under 510(k) number K970156. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMEX FUTURALDOP PRO?

IMEX FUTURALDOP PRO is a medical device that received FDA 510(k) clearance on 1997-04-04. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K970156.

When did IMEX FUTURALDOP PRO receive FDA 510(k) clearance?

IMEX FUTURALDOP PRO received FDA 510(k) clearance on 1997-04-04, under 510(k) number K970156.

Who is the listed applicant for IMEX FUTURALDOP PRO?

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 IMEX FUTURALDOP PRO?

The FDA product code for IMEX FUTURALDOP PRO is IYO.

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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 STETHODOPK942243IMEX 8000 PERSONAL CASCULAR LABK944196IMWXDOP IRK942441IMEXDOP CT+

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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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