The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Modified Conchatherm Iii Controlled Heater.
| Device ID | K884150 |
| 510k Number | K884150 |
| Device Name: | MODIFIED CONCHATHERM III CONTROLLED HEATER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
| Contact | William H Murphy |
| Correspondent | William H Murphy RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-03 |
| Decision Date | 1988-11-21 |