FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ABPMpro
K Number: K231104
·
Decision Nov 27, 2023
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
7
Review Days
222
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Basic Information
- Device Name
- ABPMpro
- K Number
- K231104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somnomedics GmbH
- Date Received
- April 19, 2023
- Decision Date
- November 27, 2023
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Somnomedics GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K240700 | HomeSleepTest (HST, HST REM+) | Dec 8, 2024 | 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 |
| K071556 | SOMNOSCREEN EEG10-20 | Jul 18, 2007 | Substantially Equivalent |