FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO LAP TOP VENTILATOR (LTV)
K Number: K010608
·
Decision Mar 20, 2001
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
498
Applicant Total
12
Review Days
19
Basic Information
- Device Name
- MODIFICATION TO LAP TOP VENTILATOR (LTV)
- K Number
- K010608
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PULMONETIC SYSTEMS, INC.
- Date Received
- March 1, 2001
- Decision Date
- March 20, 2001
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by PULMONETIC SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | Mar 18, 2009 | Substantially Equivalent |
| K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 | Aug 1, 2007 | Substantially Equivalent |
| K060647 | LTV 1200 VENTILATOR | May 25, 2006 | Substantially Equivalent |
| K060549 | AUTOMOBILE LIGHTER POWER CORD | May 4, 2006 | Substantially Equivalent |
| K051767 | LTV 1000 VENTILATOR | Jul 29, 2005 | Substantially Equivalent |
| K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS | Jun 3, 2004 | Substantially Equivalent |
| K040540 | MODIFICATION TO LTV 1000 VENTILATOR | Apr 29, 2004 | Substantially Equivalent |
| K032226 | LTV-1000 VENTILATOR | Oct 16, 2003 | Substantially Equivalent |
| K002881 | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 | Oct 11, 2000 | Substantially Equivalent - Subject to Tracking Reg. |
| K984056 | LTV 1000 | Apr 12, 1999 | Substantially Equivalent |