NEWCOR
FDA 510(k) clearance K020440 · decided 2002-12-03
Clearance details
- K-number
- K020440
- Device name
- NEWCOR
- Applicant
- Siemens Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-11
- Decision date
- 2002-12-03
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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