AViTA Pulse Oximeter (SP61)
K-Number: K252448 · 2026-02-27
Device Summary
Frequently Asked Questions
What is the AViTA Pulse Oximeter (SP61)?
AViTA Pulse Oximeter (SP61) is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Avita Corporation. The 510(k) number is K252448.
When did AViTA Pulse Oximeter (SP61) receive FDA 510(k) clearance?
AViTA Pulse Oximeter (SP61) received FDA 510(k) clearance on 2026-02-27, under 510(k) number K252448.
Who is the listed applicant for AViTA Pulse Oximeter (SP61)?
The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AViTA Pulse Oximeter (SP61)?
The FDA product code for AViTA Pulse Oximeter (SP61) is DQA.
Other records listing Avita Corporation 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: DQA)
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.