Intra.Ox 2.0 Handheld Tissue Oximeter
K-Number: K221010 · 2022-05-03
Device Summary
Frequently Asked Questions
What is the Intra.Ox 2.0 Handheld Tissue Oximeter?
Intra.Ox 2.0 Handheld Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2022-05-03. The listed applicant is Vioptix, Inc.. The 510(k) number is K221010.
When did Intra.Ox 2.0 Handheld Tissue Oximeter receive FDA 510(k) clearance?
Intra.Ox 2.0 Handheld Tissue Oximeter received FDA 510(k) clearance on 2022-05-03, under 510(k) number K221010.
Who is the listed applicant for Intra.Ox 2.0 Handheld Tissue Oximeter?
The FDA 510(k) record lists Vioptix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Intra.Ox 2.0 Handheld Tissue Oximeter?
The FDA product code for Intra.Ox 2.0 Handheld Tissue Oximeter is MUD.
Other records listing Vioptix, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MUD)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.