510(k) K223573
- Device
- Onera Sleep Test System (Onera STS)
- Applicant
- Onera B.V.
- 510(k) number
- K223573
- Product code
- MNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-18
- Date received
- 2022-11-30
- Regulation
- 868.2375
- Classification name
- Ventilatory Effort Recorder
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Ruben de Francisco Martin
- Address
- Torenallee 42-54 Eindhoven NL 5617BD 5617BD
FDA Registration Numbers
- 3010272829
- 1118193
- 1529102
- 3010157426
- 3009351773
- 3016998644
- 3003832357
- 3011061417
- 3002912391
- 3038274470
- 3009001657
- 3015529350
- 3006125362
- 3007799743
- 3033715634
- 2011171
- 3012302888
- 3018783526
- 3006258337
- 9611295
- 3012305175
- 3005873568
- 3026753386
- 3022315836
- 3006606984
- 3017684630
- 3009770872
- 3011120183
- 3036722175
- 1423640
- 3003616071
- 3007389703
- 3013689228
- 3009498109
- 9614500
- 3004531588
- 3011782009
- 3007616088
- 3016939722
- 3006463573
- 3008253300
- 9612330
- 3004604967
- 3008820594
- 3023272766
- 3004748541
- 3004016520
- 3004428458
- 3006606827
- 1063925
- 2518422
- 3002736372
- 1417592
- 3005581270
- 3007583504
- 3010399798
- 3038185755
- 3020283264
- 3008208119
- 3000126629
- 9615102
- 3013724298
- 9613619
- 3033526676
- 3024891505
- 3002806730
- 2132556
- 1650946
- 3018117195
- 3002797442
- 9617286
- 3011205710
- 3032906215
- 3017638059
- 3007573469
- 3024722701
- 2184161
- 8044004
- 3004964738
Source Documents
Other 510(k) Records For Product Code MNR
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|---|---|---|---|
| K252628 | CASSIE | Wesper, Inc. | 2026-04-27 |
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| K252383 | Somfit D | Compumedics Limited | 2025-08-28 |
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| K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | 2025-06-18 |
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| K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | 2025-02-03 |
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| K231667 | Withings Sleep Rx | Withings | 2024-09-06 |
| K233501 | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. | 2024-07-26 |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | 2024-07-15 |