510(k) K861396
K861396 is an FDA 510(k) premarket notification submitted by Spark Instruments & Academics, Inc. for the device "HANDHELD DYNAMOMETER, MODEL #160 AND #111". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code HRW (Dynamometer, Nonpowered), a Class I device regulated under 21 CFR 888.1250. Spark Instruments & Academics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1986
- Date Received
- April 15, 1986
- 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