The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Heat/moisture Exchanger, Hme, W/integral Filter.
| Device ID | K862020 |
| 510k Number | K862020 |
| Device Name: | HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Contact | Blake |
| Correspondent | Blake INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-06-30 |