FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dose IQ Safety Software
K Number: K211124
·
Decision Aug 30, 2022
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
9
Applicant Total
61
Review Days
502
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Basic Information
- Device Name
- Dose IQ Safety Software
- K Number
- K211124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corporation
- Date Received
- April 15, 2021
- Decision Date
- August 30, 2022
- Product Code
- PHC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| PHC | Infusion Safety Management Software | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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