FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
K Number: K890875
·
Decision Oct 17, 1989
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
570
Applicant Total
20
Review Days
238
Basic Information
- Device Name
- CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
- K Number
- K890875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- PPG INDUSTRIES, INC.
- Date Received
- February 21, 1989
- Decision Date
- October 17, 1989
- Product Code
- DPS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |