The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Temperature Controller Model 17000.
| Device ID | K781530 |
| 510k Number | K781530 |
| Device Name: | TEMPERATURE CONTROLLER MODEL 17000 |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | HEALTHDYNE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-06 |
| Decision Date | 1978-11-14 |