Submission Details
| 510(k) Number | K854194 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 1985 |
| Decision Date | May 02, 1986 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
Cleared
Traditional
K854194 - IMT ULTRASONIC STRIDE MONITOR
(FDA 510(k) Clearance)
May 1986
Decision
199d
Days
—
Risk
K854194 is an FDA 510(k) clearance for the IMT ULTRASONIC STRIDE MONITOR..
Submitted by Innovative Medical Technologies, Inc. (Chicago, US). The FDA issued a Cleared decision on May 2, 1986, 199 days after receiving the submission on October 15, 1985.
This device falls under the Physical Medicine FDA review panel.
Device Classification
| Product Code | — |
| Device Class | — |