FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FREEWAY NEBULIZER COMPRESSOR
K Number: K895592
·
Decision Nov 21, 1989
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
20
Review Days
67
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Basic Information
- Device Name
- FREEWAY NEBULIZER COMPRESSOR
- K Number
- K895592
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Lifecare Services, Inc.
- Date Received
- September 15, 1989
- Decision Date
- November 21, 1989
- Product Code
- CCQ
- 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 |
|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | FDA class 1 | 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 |
| 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 |
| K842876 | PORTABLE LIFECARE VENTILATOR PLV-102 | Aug 29, 1984 | Substantially Equivalent |
| K832467 | PORTABLE LIFECARE VENTILATOR PLV-100 | Oct 20, 1983 | Substantially Equivalent |