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FDA 510(k)

CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT

K-Number: K933320 · 1994-08-17

ApplicantCardio Metrics, Inc.
Decision Date1994-08-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Metrics, Inc.. It received FDA 510(k) clearance on 1994-08-17 under 510(k) number K933320. 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 CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT?

CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K933320.

When did CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT receive FDA 510(k) clearance?

CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT received FDA 510(k) clearance on 1994-08-17, under 510(k) number K933320.

Who is the listed applicant for CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT?

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

What is the FDA product code for CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT?

The FDA product code for CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT is IYO.

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Other records listing Cardio Metrics, 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.

K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESK965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEMK951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIREK961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)

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Related Devices (Code: IYO)

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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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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