The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Dabc Nonconductive Heated Anesth. Breath. Circuit.
| Device ID | K881231 |
| 510k Number | K881231 |
| Device Name: | DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | James W Pope |
| Correspondent | James W Pope INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-07-01 |