Twilight Full Face Mask
FDA 510(k) K070321 · Invacare Corp.
510(k) numberK070321
Submission
- Device name
- Twilight Full Face Mask
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- February 2, 2007
- Decision date
- April 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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Questions and answers
When was Twilight Full Face Mask cleared by the FDA?
Twilight Full Face Mask (K070321) received a 510(k) decision of Substantially Equivalent on April 30, 2007, 87 days after the submission was received.
What is the product code of K070321?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.