510(k) K802217
K802217 is an FDA 510(k) premarket notification submitted by Med-Western Electronics, Inc. for the device "VIEW-LITE, MODEL-SL". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. Med-Western Electronics, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1980
- Date Received
- September 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Illuminator, Radiographic-Film
- Device Class
- Class I
- Regulation Number
- 892.1890
- Review Panel
- RA
- Submission Type