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FDA 510(k)

RANDOX TRI LEVEL CARDIAC CONTROL

K-Number: K041361 · 2004-09-09

ApplicantRandox Laboratories Limited
Decision Date2004-09-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX TRI LEVEL CARDIAC CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2004-09-09 under 510(k) number K041361. 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 RANDOX TRI LEVEL CARDIAC CONTROL?

RANDOX TRI LEVEL CARDIAC CONTROL is a medical device that received FDA 510(k) clearance on 2004-09-09. The listed applicant is Randox Laboratories Limited. The 510(k) number is K041361.

When did RANDOX TRI LEVEL CARDIAC CONTROL receive FDA 510(k) clearance?

RANDOX TRI LEVEL CARDIAC CONTROL received FDA 510(k) clearance on 2004-09-09, under 510(k) number K041361.

Who is the listed applicant for RANDOX TRI LEVEL CARDIAC CONTROL?

The FDA 510(k) record lists Randox Laboratories Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RANDOX TRI LEVEL CARDIAC CONTROL?

The FDA product code for RANDOX TRI LEVEL CARDIAC CONTROL is JJY.

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Other records listing Randox Laboratories Limited as applicant

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Related Devices (Code: 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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