FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMNOSCREEN EEG10-20
K Number: K071556
·
Decision Jul 18, 2007
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
7
Review Days
41
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SOMNOSCREEN EEG10-20
- K Number
- K071556
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somnomedics GmbH
- Date Received
- June 7, 2007
- Decision Date
- July 18, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNR), ordered by most recent decision date.
CASSIE
FDA 510(k)
FDA Class 2
·Anesthesiology
SANSA HSAT
FDA 510(k)
FDA Class 2
·Anesthesiology
SANSA HSAT
FDA 510(k)
FDA Class 2
·Anesthesiology
WatchPAT400 (WP400)
FDA 510(k)
FDA Class 2
·Anesthesiology
Somfit D
FDA 510(k)
FDA Class 2
·Anesthesiology
Onera STS 2 (ONERA STS 2)
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K201054 | SOMNOscreen plus | Aug 12, 2020 | Substantially Equivalent |
| K140861 | SOMNOTOUCH RESP | Jan 30, 2015 | Substantially Equivalent |
| K081485 | SOMNOWATCH | Sep 18, 2008 | Substantially Equivalent |