The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Hepa Filtered Heat And Moisture Exchanger.
| Device ID | K935036 |
| 510k Number | K935036 |
| Device Name: | HEPA FILTERED HEAT AND MOISTURE EXCHANGER |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-01-25 |