FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K Number: K072157
·
Decision Aug 27, 2007
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
120
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
- K Number
- K072157
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ohmeda Medical
- Date Received
- August 3, 2007
- Decision Date
- August 27, 2007
- Product Code
- FMT
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMT), ordered by most recent decision date.
Babyroo TN300
FDA 510(k)
FDA Class 2
·General Hospital
Babyroo TN300
FDA 510(k)
FDA Class 2
·General Hospital
Giraffe Omnibed Carestation CS1
FDA 510(k)
FDA Class 2
·General Hospital
Panda iRes Warmer, Giraffe Warmer
FDA 510(k)
FDA Class 2
·General Hospital
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
FDA 510(k)
FDA Class 2
·General Hospital
Hydro-Temp Neonatal Skin Temperature Probe Cover
FDA 510(k)
FDA Class 2
·General Hospital
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 |
| 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 |
| K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR | May 9, 2002 | Substantially Equivalent |