Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664— 510(k) K171303
Substantially EquivalentUniversity of Texas Medical School AT Houston, Texas
FDA 510(k) clearance K171303 for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664, Substantially Equivalent on 2017-09-22. Applicant: University of Texas Medical School AT Houston, Texas. Device class: 2.
Clearance details
- Applicant
- University of Texas Medical School AT Houston, Texas
- 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
- Houston, TX, US
Recent devices under product code KPS
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