Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310
FDA 510(k) K092029 · Draeger Medical AG & Co. KG
510(k) numberK092029
Submission
- Device name
- Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310
- Applicant
- Draeger Medical AG & Co. KG
Telford, PA, US - Received
- July 6, 2009
- Decision date
- August 6, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310 cleared by the FDA?
Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310 (K092029) received a 510(k) decision of Substantially Equivalent on August 6, 2010, 396 days after the submission was received.
What is the product code of K092029?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.