FDA 510(k)

12 RL ALGORITHM

K-Number: K060307 · 2006-08-04

ApplicantGe Medical Systems Information Technologies

Decision Date2006-08-04

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

12 RL ALGORITHM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2006-08-04 under 510(k) number K060307. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 12 RL ALGORITHM?

12 RL ALGORITHM is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K060307.

When did 12 RL ALGORITHM receive FDA 510(k) clearance?

12 RL ALGORITHM received FDA 510(k) clearance on 2006-08-04, under 510(k) number K060307.

Who is the listed applicant for 12 RL ALGORITHM?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 12 RL ALGORITHM?

The FDA product code for 12 RL ALGORITHM is DRT.

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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.