GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
FDA 510(k) clearance K012383 · decided 2001-10-02
Clearance details
- K-number
- K012383
- Device name
- GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
- Applicant
- Alaris Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-27
- Decision date
- 2001-10-02
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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