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FDA 510(k)

VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)

K-Number: K853737 · 1986-02-13

ApplicantCapintec, Inc.
Decision Date1986-02-13
Product CodeIYY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 1986-02-13 under 510(k) number K853737. The device is classified under product code IYY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)?

VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) is a medical device that received FDA 510(k) clearance on 1986-02-13. The listed applicant is Capintec, Inc.. The 510(k) number is K853737.

When did VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) receive FDA 510(k) clearance?

VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) received FDA 510(k) clearance on 1986-02-13, under 510(k) number K853737.

Who is the listed applicant for VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)?

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

What is the FDA product code for VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)?

The FDA product code for VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) is IYY.

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 Capintec, 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.

K192199CRC PC Smart Chamber K1K162394CRC-77tHRK101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWK071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSK052595CRC 15ULTRAK0301752 BASIC

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Related Devices (Code: IYY)

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.

K790213GENERATOR, R-WAVEAmr Co.K780510NUCLEAR STETHOSCOPEBios, 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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