The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Colby Level Alarm.
| Device ID | K863955 |
| 510k Number | K863955 |
| Device Name: | COLBY LEVEL ALARM |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
| Contact | Phyllis Piet-hughes |
| Correspondent | Phyllis Piet-hughes 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 | 1986-10-10 |
| Decision Date | 1986-11-07 |