The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Evaqmax Smoke Evacuation System.
| Device ID | K192035 |
| 510k Number | K192035 |
| Device Name: | EvaQMax Smoke Evacuation System |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | Bio Protech, Inc. 151-3, Donghwagongdan-ro, Munmak-eup Wonju-si, KR 200-801 |
| Contact | Namhyun Cho |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-07-30 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817325023566 | K192035 | 000 |
| 00850034735016 | K192035 | 000 |
| 00850034735023 | K192035 | 000 |
| 00850034735030 | K192035 | 000 |
| 10850034735129 | K192035 | 000 |
| 10850034735136 | K192035 | 000 |
| 10817325023570 | K192035 | 000 |
| 00817325023603 | K192035 | 000 |
| 00817325023610 | K192035 | 000 |
| 20817325023584 | K192035 | 000 |
| 20817325023591 | K192035 | 000 |
| 00850034735009 | K192035 | 000 |