The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Heater Wire Breathing Circuit.
| Device ID | K873179 |
| 510k Number | K873179 |
| Device Name: | HEATER WIRE BREATHING CIRCUIT |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-12 |
| Decision Date | 1988-03-31 |