The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Thera- Heat Heated Humidifier, Model Rc70000, Rc70072, Rc70075, Rc70077, Rc70012.
| Device ID | K092256 |
| 510k Number | K092256 |
| Device Name: | THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Pat Mcleish |
| Correspondent | Pat Mcleish SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2010-10-20 |
| Summary: | summary |