FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INOX IV STAND
K Number: K852300
·
Decision Jun 20, 1985
Classifications
1
FEI Numbers
278
Registration Numbers
278
Same Product Code
35
Applicant Total
6
Review Days
22
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Basic Information
- Device Name
- INOX IV STAND
- K Number
- K852300
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6990
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Broadwest Corp.
- Date Received
- May 29, 1985
- Decision Date
- June 20, 1985
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOX), ordered by most recent decision date.
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IV POLE/STAND
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IV SHUTTLE
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Other Clearances by Broadwest Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K864499 | PODOSCOPE | Feb 4, 1987 | Substantially Equivalent |
| K864569 | PODODIGITAL | Feb 4, 1987 | Substantially Equivalent |
| K852302 | INOX IORCEPS JAR | Jul 2, 1985 | Substantially Equivalent |
| K852301 | INOX THERMOMETER JAR | Jul 1, 1985 | Substantially Equivalent |
| K851307 | INOX DRY HEAT STERILIZER | May 9, 1985 | Substantially Equivalent |