K884483 is an FDA 510(k) clearance for the CRUCIOMETER. This device is classified as a Spoon, Ear (Class I - General Controls, product code JZE).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on January 18, 1989, 85 days after receiving the submission on October 25, 1988.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K884483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1988 |
| Decision Date | January 18, 1989 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | JZE — Spoon, Ear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |