The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Reusable Heated Tubing.
| Device ID | K140424 |
| 510k Number | K140424 |
| Device Name: | RESPIRONICS REUSABLE HEATED TUBING |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Alexander L Friedman |
| Correspondent | Alexander L Friedman RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-19 |
| Decision Date | 2014-11-14 |
| Summary: | summary |