FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARQUEST QC-IV TONOMETER
K Number: K855024
·
Decision Apr 7, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
32
Review Days
111
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Basic Information
- Device Name
- MARQUEST QC-IV TONOMETER
- K Number
- K855024
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Marquest Medical Products, Inc.
- Date Received
- December 17, 1985
- Decision Date
- April 7, 1986
- Product Code
- JJS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Marquest Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050066 | C-CO2 COLORIMETRIC CO2 INDICATOR | Mar 1, 2005 | Substantially Equivalent |
| K970478 | SCT 3000 HEATED HUMIDIFIER | Jul 16, 1997 | Substantially Equivalent |
| K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | Jan 14, 1997 | Substantially Equivalent |
| K962223 | WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER | Jan 14, 1997 | Substantially Equivalent |
| K960972 | DISPOSABLE GAS SAMPLING INTERFACE KITS | Oct 18, 1996 | Substantially Equivalent |
| K961838 | RESPIRGARD II, SPIROGARD | Oct 18, 1996 | Substantially Equivalent |
| K904690 | TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM | Feb 1, 1991 | Substantially Equivalent |
| K903138 | MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM | Oct 11, 1990 | Substantially Equivalent |
| K902632 | GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS | Sep 4, 1990 | Substantially Equivalent |
| K903307 | TEMP MARQ TEMPERATURE TREND INDICATOR | Aug 17, 1990 | Substantially Equivalent |