BRACHYTHERAPY SOURCE DEVICE, MODEL 9011— 510(k) K081066
Substantially EquivalentMedi-Physics, Inc., Dba GE Healthcare
FDA 510(k) clearance K081066 for BRACHYTHERAPY SOURCE DEVICE, MODEL 9011, Substantially Equivalent on 2008-05-05. Applicant: Medi-Physics, Inc., Dba GE Healthcare. Device class: 2.
Clearance details
- Applicant
- Medi-Physics, Inc., Dba GE Healthcare
- Product code
- Code IWG
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Princeton, NJ, US
Recent devices under product code IWG
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