510(k) K883702
K883702 is an FDA 510(k) premarket notification submitted by Excel Medical Products, Inc. for the device "EXCELVIEW ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on September 19, 1988. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. Excel Medical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1988
- Date Received
- August 30, 1988
- 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