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FDA 510(k)

BIOCHARGE

K-Number: K241912 · 2024-07-29

ApplicantNanofiber Solutions, LLC
Decision Date2024-07-29
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOCHARGE is a medical device manufactured by Nanofiber Solutions, LLC. It received FDA 510(k) clearance on 2024-07-29 under approval number K241912. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHARGE?

BIOCHARGE is a medical device that received FDA 510(k) clearance on 2024-07-29. It is manufactured by Nanofiber Solutions, LLC. The 510(k) number is K241912.

When was BIOCHARGE approved by the FDA?

BIOCHARGE received FDA 510(k) clearance on 2024-07-29, under approval number K241912.

What company makes BIOCHARGE?

BIOCHARGE is manufactured by Nanofiber Solutions, LLC.

What is the FDA product code for BIOCHARGE?

The FDA product code for BIOCHARGE is MAI.

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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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