510(k) K014058
K014058 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems for the device "ENTEGRA PE PERSONAL DIGITAL ASSISTANT". The FDA issued a decision of Substantially Equivalent on December 21, 2001. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. General Electric Medical Systems has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2001
- Date Received
- December 10, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type