The following data is part of a premarket notification filed by Spark Instruments & Academics, Inc. with the FDA for Handheld Dynamometer, Model #160 And #111.
| Device ID | K861396 |
| 510k Number | K861396 |
| Device Name: | HANDHELD DYNAMOMETER, MODEL #160 AND #111 |
| Classification | Dynamometer, Nonpowered |
| Applicant | SPARK INSTRUMENTS & ACADEMICS, INC. P.O. BOX 5123 Coralville, IA 52241 |
| Contact | Smidt, Ph.d. |
| Correspondent | Smidt, Ph.d. SPARK INSTRUMENTS & ACADEMICS, INC. P.O. BOX 5123 Coralville, IA 52241 |
| Product Code | HRW |
| CFR Regulation Number | 888.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-15 |
| Decision Date | 1986-05-02 |