510(k) K861396

HANDHELD DYNAMOMETER, MODEL #160 AND #111 by Spark Instruments & Academics, Inc. — Product Code HRW

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