FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Withings Sleep Rx
K Number: K231667
·
Decision Sep 6, 2024
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
7
Review Days
457
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Basic Information
- Device Name
- Withings Sleep Rx
- K Number
- K231667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Withings
- Date Received
- June 7, 2023
- Decision Date
- September 6, 2024
- Product Code
- MNR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Withings
| K Number | Device Name | ||
|---|---|---|---|
| K252474 | Withings BeamO (SCT02) | Nov 10, 2025 | Substantially Equivalent |
| K240795 | Withings ECG App | Jun 15, 2025 | Substantially Equivalent |
| K230812 | Withings Scan Monitor 2.0 | Aug 23, 2023 | Substantially Equivalent |
| K160544 | Withings Thermo (Model SCT01) | Jun 17, 2016 | Substantially Equivalent |
| K133125 | WITHINGS BLOOD PRESURE MONITOR | Mar 24, 2014 | Substantially Equivalent |
| K110872 | WITHINGS BLOOD PRESSURE MONITOR | May 20, 2011 | Substantially Equivalent |