FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Falcon HST
K Number: K242447
·
Decision Feb 20, 2025
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
9
Review Days
188
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Basic Information
- Device Name
- Falcon HST
- K Number
- K242447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compumedics Limited
- Date Received
- August 16, 2024
- Decision Date
- February 20, 2025
- Product Code
- OLV
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
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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| K072201 | COMPUMEDICS SOMTE PSG RECORDING SYSTEM | Apr 14, 2008 | Substantially Equivalent |
| K021176 | COMPUMEDICS SOMTE SYSTEM | Jan 21, 2003 | Substantially Equivalent |
| K003175 | COMPUMEDICS SIESTA SYSTEM | Dec 27, 2000 | Substantially Equivalent |