K925322 is an FDA 510(k) clearance for the A-DEC 2147 DOCTOR'S UNIT. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on December 9, 1993, 414 days after receiving the submission on October 21, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.
| 510(k) Number | K925322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1992 |
| Decision Date | December 09, 1993 |
| Days to Decision | 414 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLC — Chair, Dental, With Operative Unit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6250 |