PINNACLE3 SMARTARC— 510(k) K090808
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K090808 for PINNACLE3 SMARTARC, Substantially Equivalent on 2009-04-03. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fitchburg, WI, US
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Recalls naming K090808
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090808.
Data sourced from openFDA. This site is unofficial and independent of the FDA.