The following data is part of a premarket notification filed by James L. Geraci & Associates, Inc. with the FDA for Airmed Smoke Evacuation & Filter.
| Device ID | K820091 |
| 510k Number | K820091 |
| Device Name: | AIRMED SMOKE EVACUATION & FILTER |
| Classification | Volumetric/manometric, Carbon-dioxide |
| Applicant | JAMES L. GERACI & ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIE |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-13 |
| Decision Date | 1982-02-24 |