510(k) K003688
K003688 is an FDA 510(k) premarket notification submitted by Electromed Intl., Ltd. for the device "VIEW READING STATION". The FDA issued a decision of Substantially Equivalent on January 22, 2001. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Electromed Intl., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2001
- Date Received
- November 30, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type