BD Alaris System with Guardrails Suite MX v12.1.2
FDA 510(k) clearance K211218 · decided 2023-07-21
Clearance details
- K-number
- K211218
- Device name
- BD Alaris System with Guardrails Suite MX v12.1.2
- Applicant
- Carefusion 303, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-04-23
- Decision date
- 2023-07-21
- Days to decision
- 819 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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