FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIGGO EXACTA PRESSURE MONITORING KIT
K Number: K864900
·
Decision Apr 1, 1987
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
120
Review Days
107
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Basic Information
- Device Name
- VIGGO EXACTA PRESSURE MONITORING KIT
- K Number
- K864900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ohmeda Medical
- Date Received
- December 15, 1986
- Decision Date
- April 1, 1987
- Product Code
- FMG
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Apr 16, 2004 | Substantially Equivalent |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | May 9, 2002 | Substantially Equivalent |