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FDA 510(k)

CENTURION CARDIAC DETECTOR

K-Number: K832828 · 1984-05-09

ApplicantClinical Data Instruments, Inc.
Decision Date1984-05-09
Product CodeDRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTURION CARDIAC DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data Instruments, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K832828. The device is classified under product code DRJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTURION CARDIAC DETECTOR?

CENTURION CARDIAC DETECTOR is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Clinical Data Instruments, Inc.. The 510(k) number is K832828.

When did CENTURION CARDIAC DETECTOR receive FDA 510(k) clearance?

CENTURION CARDIAC DETECTOR received FDA 510(k) clearance on 1984-05-09, under 510(k) number K832828.

Who is the listed applicant for CENTURION CARDIAC DETECTOR?

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

What is the FDA product code for CENTURION CARDIAC DETECTOR?

The FDA product code for CENTURION CARDIAC DETECTOR is DRJ.

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Other records listing Clinical Data 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.

K842349AMBULATORY PH RECORDING DEVICEK832829NEO-FLOAT NEONATAL FLOTATION SYS & RHYT

Related Devices (Code: DRJ)

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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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