FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
K Number: K072201
·
Decision Apr 14, 2008
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
9
Review Days
250
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Basic Information
- Device Name
- COMPUMEDICS SOMTE PSG RECORDING SYSTEM
- K Number
- K072201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compumedics Limited
- Date Received
- August 8, 2007
- Decision Date
- April 14, 2008
- 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 Compumedics Limited
| K Number | Device Name | ||
|---|---|---|---|
| K252383 | Somfit D | Aug 28, 2025 | Substantially Equivalent |
| K242447 | Falcon HST | Feb 20, 2025 | Substantially Equivalent |
| K231546 | Somfit | Nov 30, 2023 | Substantially Equivalent |
| K230073 | Okti | Feb 9, 2023 | Substantially Equivalent |
| K191785 | Orion LifeSpan MEG | Feb 14, 2020 | Substantially Equivalent |
| K093223 | COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG | Jan 15, 2010 | Substantially Equivalent |
| K021176 | COMPUMEDICS SOMTE SYSTEM | Jan 21, 2003 | Substantially Equivalent |
| K003175 | COMPUMEDICS SIESTA SYSTEM | Dec 27, 2000 | Substantially Equivalent |