Classicstar NV Se and Novastar NV Se and Aav Full Face Masks
FDA 510(k) K081743 · Draeger Medical AG & Co. KG
510(k) numberK081743
Submission
- Device name
- Classicstar NV Se and Novastar NV Se and Aav Full Face Masks
- Applicant
- Draeger Medical AG & Co. KG
Luebeck, DE - Received
- June 19, 2008
- Decision date
- September 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K253647 | Evita (V800); Evita (V600)CBK · Traditional | Draegerwerk AG & CO Kgaa | 05/07/2026SE |
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| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
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| K102618 | Ventstar Heated, Infinity Id Breathing Circuit HeatedBTT · Traditional | 12/10/2010SE |
| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | 08/06/2010SE |
| K100941 | Infinity Mcable - Mainstream CO2CCK · Special | 04/23/2010SE |
| K092999 | NBP CuffDXQ · Traditional | 11/24/2009SE |
| K083050 | Evite XLCBK · Special | 12/29/2008SE |
| K081447 | Fourth Gas Module with CO2 for Primus US ApolloBSZ · Traditional | 10/08/2008SE |
Questions and answers
When was Classicstar NV Se and Novastar NV Se and Aav Full Face Masks cleared by the FDA?
Classicstar NV Se and Novastar NV Se and Aav Full Face Masks (K081743) received a 510(k) decision of Substantially Equivalent on September 22, 2008, 95 days after the submission was received.
What is the product code of K081743?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.