ELECTROCYN soma
K-Number: K220286 · 2022-12-21
Device Summary
ELECTROCYN soma is a medical device manufactured by V3Bio Sdn. Bhd. It received FDA 510(k) clearance on 2022-12-21 under approval number K220286. 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 ELECTROCYN soma?
ELECTROCYN soma is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by V3Bio Sdn. Bhd. The 510(k) number is K220286.
When was ELECTROCYN soma approved by the FDA?
ELECTROCYN soma received FDA 510(k) clearance on 2022-12-21, under approval number K220286.
What company makes ELECTROCYN soma?
ELECTROCYN soma is manufactured by V3Bio Sdn. Bhd.
What is the FDA product code for ELECTROCYN soma?
The FDA product code for ELECTROCYN soma is FRO. This falls under the Anesthesiology category.
Related Devices (Code: FRO)
K160695Talymed SuspensionMarine Polymer Technologies, Inc.
K160872PolyPlex Wound DressingGlobal Health Solutions, LLC
K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc.
K152533Xonrid GelHelsinn Healthcare SA
K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation
K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC
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.