510(k) K862616
K862616 is an FDA 510(k) premarket notification submitted by Old Delft Corp. of America for the device "AMBER-CHEST". The FDA issued a decision of Substantially Equivalent on September 2, 1986. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Old Delft Corp. of America has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1986
- Date Received
- July 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type