510(k) K801719
K801719 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code HRW (Dynamometer, Nonpowered), a Class I device regulated under 21 CFR 888.1250. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1980
- Date Received
- July 24, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dynamometer, Nonpowered
- Device Class
- Class I
- Regulation Number
- 888.1250
- Review Panel
- NE
- Submission Type