OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX— 510(k) K091628
Substantially EquivalentProtec GmbH & Co. KG
FDA 510(k) clearance K091628 for OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX, Substantially Equivalent on 2009-08-21. Applicant: Protec GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Protec GmbH & Co. KG
- Product code
- Code IXW
- Device class
- Class 2
- Regulation
- 21 CFR 892.1900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oberstenfeld, DE
Recent devices under product code IXW
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