FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SEER 1000
K Number: K130785
·
Decision Jul 26, 2013
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
59
Applicant Total
8
Review Days
127
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Basic Information
- Device Name
- SEER 1000
- K Number
- K130785
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Getemed Medizin- Und Informationstechnik AG
- Date Received
- March 21, 2013
- Decision Date
- July 26, 2013
- Product Code
- MWJ
- 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 |
|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K162023 | CardioDay V2.5 | Mar 24, 2017 | Substantially Equivalent |
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| K122272 | CARDIOMEM | Mar 28, 2013 | Substantially Equivalent |
| K063042 | CARDIOMEM CM 3000-12BT | May 30, 2007 | Substantially Equivalent |
| K070280 | CARDIODAY, VERSION 2.0 | Feb 23, 2007 | Substantially Equivalent |
| K051686 | CARDIOMEM CM 3000-12 | Jul 14, 2005 | Substantially Equivalent |
| K051471 | CARDIODAY | Jun 29, 2005 | Substantially Equivalent |