The following data is part of a premarket notification filed by Spark Instruments & Academics, Inc. with the FDA for Muscle Examination & Exercise Dosimeter (meed) Sys.
| Device ID | K884165 |
| 510k Number | K884165 |
| Device Name: | MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS |
| Classification | Dynamometer, Ac-powered |
| Applicant | SPARK INSTRUMENTS & ACADEMICS, INC. P.O. BOX 5123 Coralville, IA 52241 |
| Contact | Smidt, Phd |
| Correspondent | Smidt, Phd SPARK INSTRUMENTS & ACADEMICS, INC. P.O. BOX 5123 Coralville, IA 52241 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-04 |
| Decision Date | 1988-10-26 |