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FDA 510(k)

EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE

K-Number: K911320 · 1991-12-18

ApplicantApplied Biometrics, Inc.
Decision Date1991-12-18
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Biometrics, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K911320. 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 EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE?

EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Applied Biometrics, Inc.. The 510(k) number is K911320.

When did EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE receive FDA 510(k) clearance?

EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE received FDA 510(k) clearance on 1991-12-18, under 510(k) number K911320.

Who is the listed applicant for EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE?

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

What is the FDA product code for EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE?

The FDA product code for EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE is JOP.

Related Clinical Trials

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Other records listing Applied Biometrics, 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.

K912562ABCOM 2000K870857ABCOM 1 CARDIAC OUTPUT MONITOR

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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