Breas PV 10I CPAP System, Model PV 10I
FDA 510(k) K030985 · Vital Signs, Inc.
510(k) numberK030985
Submission
- Device name
- Breas PV 10I CPAP System, Model PV 10I
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- March 28, 2003
- Decision date
- October 15, 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 Breas PV 10I CPAP System, Model PV 10I cleared by the FDA?
Breas PV 10I CPAP System, Model PV 10I (K030985) received a 510(k) decision of Substantially Equivalent on October 15, 2003, 201 days after the submission was received.
What is the product code of K030985?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.