SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
FDA 510(k) clearance K042121 · decided 2004-08-26
Clearance details
- K-number
- K042121
- Device name
- SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
- Applicant
- Sigma Intl.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-06
- Decision date
- 2004-08-26
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Medina, NY, US
- Third-party review
- Yes
- Expedited review
- No
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