510(k) K861431
K861431 is an FDA 510(k) premarket notification submitted by Old Delft Corp. of America for the device "THERAPAX HT 150T". The FDA issued a decision of Substantially Equivalent on May 21, 1986. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Old Delft Corp. of America has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1986
- Date Received
- April 16, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Therapeutic, X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type