LTV-1000 VENTILATOR
FDA 510(k) clearance K032226 · decided 2003-10-16
Clearance details
- K-number
- K032226
- Device name
- LTV-1000 VENTILATOR
- Applicant
- Pulmonetic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-21
- Decision date
- 2003-10-16
- Days to decision
- 87 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 |
|---|---|---|
| The LTV Series ventilators provides continuous or intermittent ventilatory support for the recall (Z-1485-04) | Cardinal Health 203, Inc | 2004-09-28 |