Microlyte Ag
K-Number: K153756 · 2016-08-04
ApplicantImbed Biosciences, Inc.
Decision Date2016-08-04
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Microlyte Ag is a medical device manufactured by Imbed Biosciences, Inc.. It received FDA 510(k) clearance on 2016-08-04 under approval number K153756. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Microlyte Ag?
Microlyte Ag is a medical device that received FDA 510(k) clearance on 2016-08-04. It is manufactured by Imbed Biosciences, Inc.. The 510(k) number is K153756.
When was Microlyte Ag approved by the FDA?
Microlyte Ag received FDA 510(k) clearance on 2016-08-04, under approval number K153756.
What company makes Microlyte Ag?
Microlyte Ag is manufactured by Imbed Biosciences, Inc..
What is the FDA product code for Microlyte Ag?
The FDA product code for Microlyte Ag is FRO. This falls under the Anesthesiology category.
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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.