FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTABLE LIFECARE VENTILATOR PLV-102
K Number: K842876
·
Decision Aug 29, 1984
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
20
Review Days
37
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Basic Information
- Device Name
- PORTABLE LIFECARE VENTILATOR PLV-102
- K Number
- K842876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Lifecare Services, Inc.
- Date Received
- July 23, 1984
- Decision Date
- August 29, 1984
- 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 Lifecare Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913423 | LIFECARE REMOTE ALARM II | Jan 30, 1992 | Substantially Equivalent |
| K912224 | LIFECARE CPAP-100 | Sep 23, 1991 | Substantially Equivalent |
| K910947 | NEV-10 NEGATIVE PRESSURE VENTILATOR | Jun 3, 1991 | Substantially Equivalent |
| K894779 | LIFECARE NASAL MASK KIT CAT. NO. 06-800 | Jan 12, 1990 | Substantially Equivalent |
| K895592 | FREEWAY NEBULIZER COMPRESSOR | Nov 21, 1989 | Substantially Equivalent |
| K894361 | LIFECARE PRESSURE ALARM CAT. NO. 34-010 | Oct 5, 1989 | Substantially Equivalent |
| K880378 | LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 | Sep 30, 1988 | Substantially Equivalent |
| K873570 | LIFECARE EXHALATION VALVE #06-699 | Nov 30, 1987 | Substantially Equivalent |
| K862212 | LIFECARE REMOTE ALARM #34-001 | Jun 23, 1986 | Substantially Equivalent |
| K832467 | PORTABLE LIFECARE VENTILATOR PLV-100 | Oct 20, 1983 | Substantially Equivalent |