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FDA 510(k)

CAPTUS 500

K-Number: K921428 · 1992-05-28

ApplicantCapintec Instruments, Inc.
Decision Date1992-05-28
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAPTUS 500 is the device name listed in this FDA 510(k) record. The listed applicant is Capintec Instruments, Inc.. It received FDA 510(k) clearance on 1992-05-28 under 510(k) number K921428. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPTUS 500?

CAPTUS 500 is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Capintec Instruments, Inc.. The 510(k) number is K921428.

When did CAPTUS 500 receive FDA 510(k) clearance?

CAPTUS 500 received FDA 510(k) clearance on 1992-05-28, under 510(k) number K921428.

Who is the listed applicant for CAPTUS 500?

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

What is the FDA product code for CAPTUS 500?

The FDA product code for CAPTUS 500 is IZD.

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Other records listing Capintec Instruments, 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.

K943072BETA C COUNTERK935539CAPINTEC CRC 35RK930962CAPTUS 2000 WEL COUNTERK924586CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWAREK910020CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELSK905796DOSE CALIBRATOR

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Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.

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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