Positive Airway Pressure System
FDA 510(k) K933184 · Innovative Medical Systems, Inc.
510(k) numberK933184
Submission
- Device name
- Positive Airway Pressure System
- Applicant
- Innovative Medical Systems, Inc.
Hampton, NH, US - Received
- June 30, 1993
- Decision date
- November 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Positive Airway Pressure System cleared by the FDA?
Positive Airway Pressure System (K933184) received a 510(k) decision of Substantially Equivalent on November 28, 1994, 516 days after the submission was received.
What is the product code of K933184?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.