510(k) K943602
K943602 is an FDA 510(k) premarket notification submitted by Miles Inc., Agfa Division for the device "DI-2000". The FDA issued a decision of Substantially Equivalent on May 12, 1995. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Miles Inc., Agfa Division has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1995
- Date Received
- July 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Scintillation (Gamma)
- Device Class
- Class I
- Regulation Number
- 892.1100
- Review Panel
- RA
- Submission Type