FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
MONITORING SYSTEM, MODEL ARGUS PB-2200
K Number: K033738
·
Decision Aug 24, 2004
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
16
Review Days
270
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Basic Information
- Device Name
- MONITORING SYSTEM, MODEL ARGUS PB-2200
- K Number
- K033738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schiller AG
- Date Received
- November 28, 2003
- Decision Date
- August 24, 2004
- Product Code
- DSK
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | FDA class 2 | Cardiovascular |
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| K050686 | CARDIOVIT AT-10PLUS | May 4, 2005 | Substantially Equivalent |
| K031557 | CARDIOVIT AT-102 | Apr 14, 2004 | Substantially Equivalent |