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FDA 510(k)

DOPLETTE 10

K-Number: K851269 · 1985-07-29

ApplicantImex Medical Systems, Inc.
Decision Date1985-07-29
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOPLETTE 10 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 1985-07-29 under 510(k) number K851269. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPLETTE 10?

DOPLETTE 10 is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K851269.

When did DOPLETTE 10 receive FDA 510(k) clearance?

DOPLETTE 10 received FDA 510(k) clearance on 1985-07-29, under 510(k) number K851269.

Who is the listed applicant for DOPLETTE 10?

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 DOPLETTE 10?

The FDA product code for DOPLETTE 10 is JOP.

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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: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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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