The following data is part of a premarket notification filed by Inhalation Plastics with the FDA for Thermo-flow Set.
| Device ID | K914686 |
| 510k Number | K914686 |
| Device Name: | THERMO-FLOW SET |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | INHALATION PLASTICS 3217 N. KILPATRICK AVE. Chicago, IL 60641 |
| Contact | Jim Lekkas |
| Correspondent | Jim Lekkas INHALATION PLASTICS 3217 N. KILPATRICK AVE. Chicago, IL 60641 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1992-04-15 |