FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXSYS MOBILEMATE EQUIPMENT STAND
K Number: K944580
·
Decision Mar 17, 1995
Classifications
1
FEI Numbers
278
Registration Numbers
278
Same Product Code
35
Applicant Total
33
Review Days
179
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Basic Information
- Device Name
- FLEXSYS MOBILEMATE EQUIPMENT STAND
- K Number
- K944580
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6990
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom, Inc.
- Date Received
- September 19, 1994
- Decision Date
- March 17, 1995
- Product Code
- FOX
- 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 |
|---|---|---|---|
| FOX | Stand, Infusion | FDA class 1 | General Hospital |
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