FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STABIL-O-GRAPH
K Number: K041313
·
Decision Jun 18, 2004
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
5
Review Days
32
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Basic Information
- Device Name
- STABIL-O-GRAPH
- K Number
- K041313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I.E.M. GmbH
- Date Received
- May 17, 2004
- Decision Date
- June 18, 2004
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K153557 | ABPM 7100, Hypertension Management Software | Jul 19, 2016 | Substantially Equivalent |
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| K110603 | HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) | Dec 16, 2011 | Substantially Equivalent |
| K072446 | MOBIL-O-GRAPH NG 24 H ABP-CONTROL | Nov 29, 2007 | Substantially Equivalent |