The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Thera-heat Heated Humidifier And Adult Dual And Single Limb Heated Wire Ventilator Breathing Circuits.
| Device ID | K071958 |
| 510k Number | K071958 |
| Device Name: | THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Christine Lloyd |
| Correspondent | Christine Lloyd 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 | 2007-07-16 |
| Decision Date | 2007-11-21 |
| Summary: | summary |