The following data is part of a premarket notification filed by Fitness Motivation Institute Of America with the FDA for Isorobic Skinfold Caliper.
| Device ID | K810116 |
| 510k Number | K810116 |
| Device Name: | ISOROBIC SKINFOLD CALIPER |
| Classification | Caliper |
| Applicant | FITNESS MOTIVATION INSTITUTE OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTZ |
| CFR Regulation Number | 888.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-15 |
| Decision Date | 1981-02-04 |