BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
FDA 510(k) clearance K110383 · decided 2011-08-01
Clearance details
- K-number
- K110383
- Device name
- BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
- Applicant
- A Plus Medical
- Decision
- Substantially Equivalent
- Date received
- 2011-02-10
- Decision date
- 2011-08-01
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562 recall (Z-0020-2020) | Galemed Corporation | 2019-12-20 |
| Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, U recall (Z-0021-2020) | Galemed Corporation | 2019-12-20 |
| Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port recall (Z-0022-2020) | Galemed Corporation | 2019-12-20 |
| Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators. recall (Z-0009-2020) | TELEFLEX-MORRISVILLE | 2019-11-07 |