K843855 is an FDA 510(k) clearance for the ERGOTEST 40 & 45. This device is classified as a Valve, Prosthesis (Class I - General Controls, product code ISP).
Submitted by Erich Jaeger, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1984, 57 days after receiving the submission on October 1, 1984.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3420.
| 510(k) Number | K843855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1984 |
| Decision Date | November 27, 1984 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ISP — Valve, Prosthesis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3420 |