Submission Details
| 510(k) Number | K854741 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 1985 |
| Decision Date | March 06, 1986 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
Cleared
Traditional
X-RANGE 65
Mar 1986
Decision
101d
Days
Class 2
Risk
About This 510(k) Submission
K854741 is an FDA 510(k) clearance for the X-RANGE 65, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 6, 1986, 101 days after receiving the submission on November 25, 1985. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
Device Classification
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |
Manufacturer
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