NEUROPET— 510(k) K091269
Substantially EquivalentPhotodetection Systems, Inc.
FDA 510(k) clearance K091269 for NEUROPET, Substantially Equivalent on 2009-05-08. Applicant: Photodetection Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Photodetection Systems, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boxborough, MA, US
Recent devices under product code KPS
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