The following data is part of a premarket notification filed by Onera B.v. with the FDA for Onera Sleep Test System (onera Sts).
| Device ID | K210593 |
| 510k Number | K210593 |
| Device Name: | Onera Sleep Test System (Onera STS) |
| Classification | Ventilatory Effort Recorder |
| Applicant | Onera B.V. Torenallee 42-54 Eindhoven, NL 5617bd |
| Contact | Ruben De Francisco Martin |
| Correspondent | Ruben De Francisco Martin Onera B.V. Torenallee 42-54 Eindhoven, NL 5617bd |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2022-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08720256698197 | K210593 | 000 |
| 08720256698012 | K210593 | 000 |
| 08720256698029 | K210593 | 000 |
| 08720256698036 | K210593 | 000 |
| 08720256698043 | K210593 | 000 |
| 08720256698050 | K210593 | 000 |
| 08720256698067 | K210593 | 000 |
| 08720256698074 | K210593 | 000 |
| 08720256698098 | K210593 | 000 |
| 08720256698111 | K210593 | 000 |
| 08720256698135 | K210593 | 000 |
| 08720256698159 | K210593 | 000 |
| 08720256698173 | K210593 | 000 |
| 08720256698005 | K210593 | 000 |