Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012
FDA 510(k) K092256 · Smiths Medical Asd, Inc.
510(k) numberK092256
Submission
- Device name
- Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012
- Applicant
- Smiths Medical Asd, Inc.
Rockland, MA, US - Received
- July 28, 2009
- Decision date
- October 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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Questions and answers
When was Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012 cleared by the FDA?
Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012 (K092256) received a 510(k) decision of Substantially Equivalent on October 20, 2010, 449 days after the submission was received.
What is the product code of K092256?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.