K912071 is an FDA 510(k) clearance for the SPACE(TM) 7500. This device is classified as a Electromyograph, Diagnostic (Class II - Special Controls, product code IKN).
Submitted by F.M. Wiest USA, Inc. (Oradell, US). The FDA issued a Cleared decision on July 9, 1991, 60 days after receiving the submission on May 10, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K912071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1991 |
| Decision Date | July 09, 1991 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | IKN — Electromyograph, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1375 |