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FDA 510(k)

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC

K-Number: K032089 · 2003-07-30

ApplicantRoche Diagnostics Corp.
Decision Date2003-07-30
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-07-30 under 510(k) number K032089. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC?

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC is a medical device that received FDA 510(k) clearance on 2003-07-30. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K032089.

When did ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC receive FDA 510(k) clearance?

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC received FDA 510(k) clearance on 2003-07-30, under 510(k) number K032089.

Who is the listed applicant for ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC?

The FDA product code for ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC is JJY.

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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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