FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STATPAL II BLOOD GAS ANALYSIS SYSTEM
K Number: K922631
·
Decision Nov 10, 1992
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
20
Review Days
160
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Basic Information
- Device Name
- STATPAL II BLOOD GAS ANALYSIS SYSTEM
- K Number
- K922631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ppg Industries, Inc.
- Date Received
- June 3, 1992
- Decision Date
- November 10, 1992
- Product Code
- CHL
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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Other Clearances by Ppg Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913358 | MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST | Dec 20, 1991 | Substantially Equivalent |
| K914560 | STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL | Nov 29, 1991 | Substantially Equivalent |
| K912627 | MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM | Sep 10, 1991 | Substantially Equivalent |
| K903965 | STATPAL BLOOD GAS MONITORING SYSTEM | Dec 26, 1990 | Substantially Equivalent |
| K901514 | XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. | Nov 16, 1990 | Substantially Equivalent |
| K900246 | CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 | Jul 3, 1990 | Substantially Equivalent |
| K901132 | SARA SATCAP | May 22, 1990 | Substantially Equivalent |
| K896442 | PPG BIOMEDICAL VENTILATOR MODEL IRISA | Apr 16, 1990 | Substantially Equivalent |
| K900700 | SMU 611 UNIVERSALMONITOR | Apr 3, 1990 | Substantially Equivalent |
| K890875 | CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 | Oct 17, 1989 | Substantially Equivalent |