FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENTMATE TM
K Number: K854754
·
Decision Feb 4, 1986
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
4
Review Days
69
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Basic Information
- Device Name
- PATIENTMATE TM
- K Number
- K854754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Trend Medical, Inc.
- Date Received
- November 27, 1985
- Decision Date
- February 4, 1986
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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