FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
InPen System
K Number: K192841
·
Decision Feb 10, 2020
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
54
Applicant Total
5
Review Days
130
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Basic Information
- Device Name
- InPen System
- K Number
- K192841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Companion Medical, Inc.
- Date Received
- October 3, 2019
- Decision Date
- February 10, 2020
- 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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