PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
FDA 510(k) clearance K083688 · decided 2009-03-18
Clearance details
- K-number
- K083688
- Device name
- PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
- Applicant
- Pulmonetic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-12
- Decision date
- 2009-03-18
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits recall (Z-2205-2010) | CareFusion 203, Inc. | 2010-08-10 |