510(k) K760301
K760301 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "GONIOMETER, MED. INTER. STAND. BK-7512". The FDA issued a decision of Substantially Equivalent on September 8, 1976. The device falls under product code KQW (Goniometer, Nonpowered), a Class I device regulated under 21 CFR 888.1520. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1976
- Date Received
- July 23, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Goniometer, Nonpowered
- Device Class
- Class I
- Regulation Number
- 888.1520
- Review Panel
- NE
- Submission Type