K830888 is an FDA 510(k) clearance for the COOL-LITE FIBERCOPTIC LARYNGEAL EXAM. This device is classified as a Laryngoscope, Nasopharyngoscope (Class II - Special Controls, product code EQN).
Submitted by National Medical Technology (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983, 37 days after receiving the submission on March 21, 1983.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4760. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K830888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1983 |
| Decision Date | April 27, 1983 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EQN — Laryngoscope, Nasopharyngoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4760 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |