FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
K Number: K880378
·
Decision Sep 30, 1988
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
20
Review Days
247
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Basic Information
- Device Name
- LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
- K Number
- K880378
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Lifecare Services, Inc.
- Date Received
- January 27, 1988
- Decision Date
- September 30, 1988
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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| K873570 | LIFECARE EXHALATION VALVE #06-699 | Nov 30, 1987 | Substantially Equivalent |
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| K842876 | PORTABLE LIFECARE VENTILATOR PLV-102 | Aug 29, 1984 | Substantially Equivalent |
| K832467 | PORTABLE LIFECARE VENTILATOR PLV-100 | Oct 20, 1983 | Substantially Equivalent |