FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEWCOR
K Number: K020440
·
Decision Dec 3, 2002
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
25
Review Days
295
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Basic Information
- Device Name
- NEWCOR
- K Number
- K020440
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Systems, Inc.
- Date Received
- February 11, 2002
- Decision Date
- December 3, 2002
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K123540 | SYNGO CT PULMO 3D | Aug 29, 2013 | Substantially Equivalent |
| K123541 | SYNGO.CT NEURO PERFUSION | Apr 2, 2013 | Substantially Equivalent |
| K122909 | SYNGO SINGLE SOURCE DUAL ENGERY | Dec 27, 2012 | Substantially Equivalent |
| K122471 | SOMATOM DEFINITION | Sep 11, 2012 | Substantially Equivalent |
| K120579 | SOMATOM DEFINITION EDGE | May 23, 2012 | Substantially Equivalent |
| K121072 | SOMATOM DEFINITION FLASH | May 8, 2012 | Substantially Equivalent |
| K113342 | SOMATOM DEFINITION FLASH | Dec 29, 2011 | Substantially Equivalent |
| K052216 | SOMATOM DEFINITION | Sep 8, 2005 | Substantially Equivalent |