Facefit and Facefit Ported Non-Invasive Ventilation Masks
FDA 510(k) K121747 · Intersurgical Incorporated
510(k) numberK121747
Submission
- Device name
- Facefit and Facefit Ported Non-Invasive Ventilation Masks
- Applicant
- Intersurgical Incorporated
Liverpool, NY, US - Received
- June 14, 2012
- Decision date
- March 14, 2013
- 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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| K253939 | DeltaWave Nasal Pillow SystemBZD · Special | RemSleep Holdings, Inc. | 01/07/2026SE |
| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
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Questions and answers
When was Facefit and Facefit Ported Non-Invasive Ventilation Masks cleared by the FDA?
Facefit and Facefit Ported Non-Invasive Ventilation Masks (K121747) received a 510(k) decision of Substantially Equivalent on March 14, 2013, 273 days after the submission was received.
What is the product code of K121747?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.