FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
COR12+
K Number: K091505
·
Decision Jun 10, 2009
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
14
Review Days
20
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Basic Information
- Device Name
- COR12+
- K Number
- K091505
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Viasys Healthcare GmbH
- Date Received
- May 21, 2009
- Decision Date
- June 10, 2009
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Viasys Healthcare GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K092324 | SPIROPRO | Sep 3, 2009 | Substantially Equivalent |
| K091412 | CLEAN PEAK FLOW METER | Aug 21, 2009 | Substantially Equivalent |
| K081823 | MASTERSCREEN PAED - BABY BODY | May 18, 2009 | Substantially Equivalent |
| K080510 | VIP PULMONARY FUNCTION SYSTEM | Aug 20, 2008 | Substantially Equivalent |
| K080734 | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT | Jun 26, 2008 | Substantially Equivalent |
| K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | Apr 22, 2008 | Substantially Equivalent |
| K072323 | MASTERSCREEN & OXYCON CPX | Oct 10, 2007 | Substantially Equivalent |
| K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE | Aug 14, 2007 | Substantially Equivalent |
| K062011 | MODIFICATION TO FLOWSCREEN | May 11, 2007 | Substantially Equivalent |
| K070614 | CORSCREEN | May 4, 2007 | Substantially Equivalent |