K072634 is an FDA 510(k) clearance for the EMG TRITON -COMP,MODEL NCA01-XXX SERIES. This device is classified as a Compressor, Air, Portable (Class II - Special Controls, product code BTI).
Submitted by Emg Technology Co., Ltd. (Shituen Chiu, Taichung, TW). The FDA issued a Cleared decision on November 19, 2008, 428 days after receiving the submission on September 18, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6250.
| 510(k) Number | K072634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2007 |
| Decision Date | November 19, 2008 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTI — Compressor, Air, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.6250 |