FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SOMNOscreen plus
K Number: K201054
·
Decision Aug 12, 2020
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
7
Review Days
113
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Basic Information
- Device Name
- SOMNOscreen plus
- K Number
- K201054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somnomedics GmbH
- Date Received
- April 21, 2020
- Decision Date
- August 12, 2020
- Product Code
- OLV
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Somnomedics GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K240700 | HomeSleepTest (HST, HST REM+) | Dec 8, 2024 | Substantially Equivalent |
| K231104 | ABPMpro | Nov 27, 2023 | Substantially Equivalent |
| K212325 | EEG-acp | Jun 15, 2022 | Substantially Equivalent |
| K140861 | SOMNOTOUCH RESP | Jan 30, 2015 | Substantially Equivalent |
| K081485 | SOMNOWATCH | Sep 18, 2008 | Substantially Equivalent |
| K071556 | SOMNOSCREEN EEG10-20 | Jul 18, 2007 | Substantially Equivalent |