FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIGGO VASCUPORT NEEDLE
K Number: K881758
·
Decision Jun 3, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
120
Review Days
39
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Basic Information
- Device Name
- VIGGO VASCUPORT NEEDLE
- K Number
- K881758
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ohmeda Medical
- Date Received
- April 25, 1988
- Decision Date
- June 3, 1988
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K101778 | GIRAFFE INCUBATOR | Jul 21, 2010 | Substantially Equivalent |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Apr 16, 2009 | Substantially Equivalent |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Aug 27, 2007 | Substantially Equivalent |
| K070377 | GIRAFFE AND PANDA WARMER | Jul 11, 2007 | Substantially Equivalent |
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | Apr 20, 2007 | Substantially Equivalent |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Apr 20, 2007 | Substantially Equivalent |
| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Apr 16, 2004 | Substantially Equivalent |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | May 9, 2002 | Substantially Equivalent |