Multi-Strap Full Face Mask
FDA 510(k) K023683 · Engineered Medical Systems
510(k) numberK023683
Submission
- Device name
- Multi-Strap Full Face Mask
- Applicant
- Engineered Medical Systems
Mccordsville, IN, US - Received
- November 1, 2002
- Decision date
- December 1, 2003
- 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 Multi-Strap Full Face Mask cleared by the FDA?
Multi-Strap Full Face Mask (K023683) received a 510(k) decision of Substantially Equivalent on December 1, 2003, 395 days after the submission was received.
What is the product code of K023683?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.