APIS (R), VERIS (TM)
K-Number: K222143 · 2023-10-13
Device Summary
APIS (R), VERIS (TM) is a medical device manufactured by Sweetbio, Inc.. It received FDA 510(k) clearance on 2023-10-13 under approval number K222143. 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 APIS (R), VERIS (TM)?
APIS (R), VERIS (TM) is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Sweetbio, Inc.. The 510(k) number is K222143.
When was APIS (R), VERIS (TM) approved by the FDA?
APIS (R), VERIS (TM) received FDA 510(k) clearance on 2023-10-13, under approval number K222143.
What company makes APIS (R), VERIS (TM)?
APIS (R), VERIS (TM) is manufactured by Sweetbio, Inc..
What is the FDA product code for APIS (R), VERIS (TM)?
The FDA product code for APIS (R), VERIS (TM) is FRO. This falls under the Anesthesiology category.
Other Devices by Sweetbio, Inc.
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.