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FDA 510(k)

POCKET DOP 3

K-Number: K910462 · 1991-06-24

ApplicantImex Medical Systems, Inc.
Decision Date1991-06-24
Product CodeHEP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

POCKET DOP 3 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 1991-06-24 under 510(k) number K910462. The device is classified under product code HEP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POCKET DOP 3?

POCKET DOP 3 is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K910462.

When did POCKET DOP 3 receive FDA 510(k) clearance?

POCKET DOP 3 received FDA 510(k) clearance on 1991-06-24, under 510(k) number K910462.

Who is the listed applicant for POCKET DOP 3?

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 POCKET DOP 3?

The FDA product code for POCKET DOP 3 is HEP.

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.

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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 LABK944196IMWXDOP IR

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Related Devices (Code: HEP)

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.

K101960SONOTRAX SERIES ULTRASONIC POCKET DOPPLEREdan Instruments, Inc.K023082BABYCAREBionet Company, Ltd.K920353ULTRACELL INSTRUMENT WIPEUltracell Medical Technologies, 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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