FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIALYSIS SYS., PDS 400 & RO 400
K Number: K781156
·
Decision Oct 24, 1978
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
30
Applicant Total
80
Review Days
105
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Basic Information
- Device Name
- DIALYSIS SYS., PDS 400 & RO 400
- K Number
- K781156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Physio-Control Corp.
- Date Received
- July 11, 1978
- Decision Date
- October 24, 1978
- Product Code
- DJC
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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| K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | Sep 26, 1995 | Substantially Equivalent |
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