FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WHISPERJECT AUTOINJECTOR
K Number: K141384
·
Decision Sep 12, 2014
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
3
Review Days
108
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Basic Information
- Device Name
- WHISPERJECT AUTOINJECTOR
- K Number
- K141384
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scandinavian Health Limited
- Date Received
- May 27, 2014
- Decision Date
- September 12, 2014
- Product Code
- KZH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
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