510(k) K943973
K943973 is an FDA 510(k) premarket notification submitted by Progressive Electrical Therapeutics for the device "EURO TECH STERLING ROLLER TABLE". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Progressive Electrical Therapeutics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1994
- Date Received
- August 15, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Physical Therapy, Multi Function
- Device Class
- Class II
- Regulation Number
- 890.5880
- Review Panel
- PM
- Submission Type