FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSPIRA HD, MODEL: NL1000
K Number: K090811
·
Decision Aug 27, 2009
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
8
Review Days
155
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Basic Information
- Device Name
- INSPIRA HD, MODEL: NL1000
- K Number
- K090811
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurologica Corporation
- Date Received
- March 25, 2009
- Decision Date
- August 27, 2009
- Product Code
- KPS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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