FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE
K Number: K941850
·
Decision Jul 14, 1994
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE
- K Number
- K941850
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tnt Moborg Intl. , Ltd.
- Date Received
- April 14, 1994
- Decision Date
- July 14, 1994
- Product Code
- KMK
- 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 |
|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | FDA class 1 | General Hospital |
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