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FDA 510(k)

ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST

K-Number: K861378 · 1986-07-07

ApplicantUltramed, Inc.
Decision Date1986-07-07
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST is the device name listed in this FDA 510(k) record. The listed applicant is Ultramed, Inc.. It received FDA 510(k) clearance on 1986-07-07 under 510(k) number K861378. 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 ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST?

ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Ultramed, Inc.. The 510(k) number is K861378.

When did ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST receive FDA 510(k) clearance?

ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST received FDA 510(k) clearance on 1986-07-07, under 510(k) number K861378.

Who is the listed applicant for ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST?

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

What is the FDA product code for ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST?

The FDA product code for ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST is JOP.

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 Ultramed, 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.

K882015TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEMK873989DOPPLEX ULTRASONIC DOPPLER SYSTEMK862021PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEMK850578PHACOEMULSIFICATION TIP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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