FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
InPen Dose Calculator
K Number: K181327
·
Decision Jul 6, 2018
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
54
Applicant Total
5
Review Days
49
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Basic Information
- Device Name
- InPen Dose Calculator
- K Number
- K181327
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Companion Medical, Inc.
- Date Received
- May 18, 2018
- Decision Date
- July 6, 2018
- Product Code
- NDC
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| NDC | Calculator, Drug Dose | FDA class 2 | Anesthesiology |
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