K771825 is an FDA 510(k) clearance for the CARBA LINGUARDUC. This device is classified as a System, Communication, Powered (Class II - Special Controls, product code ILQ).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1977, 9 days after receiving the submission on September 27, 1977.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3710.
| 510(k) Number | K771825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1977 |
| Decision Date | October 06, 1977 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILQ — System, Communication, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3710 |