FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
K Number: K890058
·
Decision Nov 21, 1989
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
11
Review Days
319
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Basic Information
- Device Name
- VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
- K Number
- K890058
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vascular Technology Incorporated
- Date Received
- January 6, 1989
- Decision Date
- November 21, 1989
- 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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Other Clearances by Vascular Technology Incorporated
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|---|---|---|---|
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| K002990 | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 | Nov 6, 2000 | Substantially Equivalent |
| K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET | Dec 27, 1994 | Substantially Equivalent |
| K922738 | VTI OXYGEN ANALYZER | Jan 27, 1993 | Substantially Equivalent |
| K883960 | GIPHY MONITOR | Oct 4, 1989 | Substantially Equivalent |
| K864583 | CARDIAC PERFORMANCE MONITOR | May 11, 1987 | Substantially Equivalent |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | Jun 25, 1986 | Substantially Equivalent |
| K862113 | NO. 100352 GALVANIC OXYGEN SENSOR | Jun 19, 1986 | Substantially Equivalent |
| K852275 | VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR | Jun 20, 1985 | Substantially Equivalent |