510(k) K812152
K812152 is an FDA 510(k) premarket notification submitted by Medical Synergy for the device "MEDI VIEW". The FDA issued a decision of Substantially Equivalent on Sep 9, 1981. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. Medical Synergy has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 1981
- Date Received
- Jul 29, 1981
- 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