The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Disposable Heated Wire Circuits.
| Device ID | K110398 |
| 510k Number | K110398 |
| Device Name: | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Joseph E Olsavsky |
| Correspondent | Joseph E Olsavsky RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-06-01 |
| Summary: | summary |