Onera Sleep Test System (Onera STS)
K-Number: K210593 · 2022-04-06
Device Summary
Frequently Asked Questions
What is the Onera Sleep Test System (Onera STS)?
Onera Sleep Test System (Onera STS) is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Onera B.V.. The 510(k) number is K210593.
When did Onera Sleep Test System (Onera STS) receive FDA 510(k) clearance?
Onera Sleep Test System (Onera STS) received FDA 510(k) clearance on 2022-04-06, under 510(k) number K210593.
Who is the listed applicant for Onera Sleep Test System (Onera STS)?
The FDA 510(k) record lists Onera B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Onera Sleep Test System (Onera STS)?
The FDA product code for Onera Sleep Test System (Onera STS) is MNR.
Other records listing Onera B.V. 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: MNR)
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.