Submission Details
| 510(k) Number | K812778 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 05, 1981 |
| Decision Date | December 08, 1981 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
Cleared
Traditional
THE TELOS EQUIPMENT
Dec 1981
Decision
64d
Days
Class 1
Risk
About This 510(k) Submission
K812778 is an FDA 510(k) clearance for the THE TELOS EQUIPMENT, a Goniometer, Nonpowered (Class I — General Controls, product code KQW), submitted by The Telos Co. (Walker, US). The FDA issued a Cleared decision on December 8, 1981, 64 days after receiving the submission on October 5, 1981. This device falls under the Radiology review panel. Regulated under 21 CFR 888.1520.
Device Classification
| Product Code | KQW — Goniometer, Nonpowered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 888.1520 |
Manufacturer
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