510(k) K953563
K953563 is an FDA 510(k) premarket notification submitted by Jamieson Film Co. for the device "VANGUARD XR-350 CINEANGIOGRAM PROJECTOR". The FDA issued a decision of Substantially Equivalent on October 5, 1995. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Jamieson Film Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1995
- Date Received
- July 31, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type