Valleylab REM Polyhesive Infant Patient Return Electrode
K-Number: K160290 · 2016-05-19
ApplicantCovidien, LLC
Decision Date2016-05-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Valleylab REM Polyhesive Infant Patient Return Electrode is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2016-05-19 under approval number K160290. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Valleylab REM Polyhesive Infant Patient Return Electrode?
Valleylab REM Polyhesive Infant Patient Return Electrode is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Covidien, LLC. The 510(k) number is K160290.
When was Valleylab REM Polyhesive Infant Patient Return Electrode approved by the FDA?
Valleylab REM Polyhesive Infant Patient Return Electrode received FDA 510(k) clearance on 2016-05-19, under approval number K160290.
What company makes Valleylab REM Polyhesive Infant Patient Return Electrode?
Valleylab REM Polyhesive Infant Patient Return Electrode is manufactured by Covidien, LLC.
What is the FDA product code for Valleylab REM Polyhesive Infant Patient Return Electrode?
The FDA product code for Valleylab REM Polyhesive Infant Patient Return Electrode is GEI.
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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.