FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K Number: K040068
·
Decision Apr 16, 2004
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
120
Review Days
93
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Basic Information
- Device Name
- BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K Number
- K040068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ohmeda Medical
- Date Received
- January 14, 2004
- Decision Date
- April 16, 2004
- Product Code
- FMZ
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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Other Clearances by Ohmeda Medical
| K Number | Device Name | ||
|---|---|---|---|
| K123309 | GIRAFFE AND PANDA WARMERS | Feb 5, 2013 | Substantially Equivalent |
| K101788 | GIRAFFE OMNIBED | Jul 21, 2010 | Substantially Equivalent |
| 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 |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | May 9, 2002 | Substantially Equivalent |
| K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR | May 9, 2002 | Substantially Equivalent |