K884723 is an FDA 510(k) clearance for the (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM. This device is classified as a Goniometer, Ac-powered (Class I — General Controls, product code KQX).
Submitted by Greenleaf Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 8, 1989, 90 days after receiving the submission on November 10, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.
| 510(k) Number | K884723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1988 |
| Decision Date | February 08, 1989 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | KQX — Goniometer, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 888.1500 |