BIPAP a 40 Ventilatory Support System
FDA 510(k) K121623 · Respironics, Inc.
510(k) numberK121623
Submission
- Device name
- BIPAP a 40 Ventilatory Support System
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- June 1, 2012
- Decision date
- December 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNT – Sv70 Ventilator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was BIPAP a 40 Ventilatory Support System cleared by the FDA?
BIPAP a 40 Ventilatory Support System (K121623) received a 510(k) decision of Substantially Equivalent on December 14, 2012, 196 days after the submission was received.
What is the product code of K121623?
The FDA product code is MNT – Sv70 Ventilator, a Class II (moderate risk) device regulated under 21 CFR 868.5895.