FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
K Number: K242769
·
Decision Apr 4, 2025
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
8
Review Days
203
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Basic Information
- Device Name
- VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
- K Number
- K242769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draegerwerk AG & CO Kgaa
- Date Received
- September 13, 2024
- Decision Date
- April 4, 2025
- Product Code
- BTL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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Other Clearances by Draegerwerk AG & CO Kgaa
| K Number | Device Name | ||
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | May 7, 2026 | Substantially Equivalent |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Jun 14, 2023 | Substantially Equivalent |
| K222024 | Evita V800, Evita V600 | May 16, 2023 | Substantially Equivalent |
| K222207 | Babylog VN800, Babylog VN600 | May 16, 2023 | Substantially Equivalent |
| K221118 | CO2 Mainstream Sensor | Apr 5, 2023 | Substantially Equivalent |
| K162821 | Babyleo TN500 | Jun 23, 2017 | Substantially Equivalent |
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | Mar 30, 2010 | Substantially Equivalent |