FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K Number: K072512
·
Decision Oct 3, 2007
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
58
Review Days
27
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Basic Information
- Device Name
- MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
- K Number
- K072512
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda, Inc.
- Date Received
- September 6, 2007
- Decision Date
- October 3, 2007
- 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 Datex-Ohmeda, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Oct 22, 2025 | Substantially Equivalent |
| K213867 | Carestation 750/750c | Mar 28, 2023 | Substantially Equivalent |
| K210384 | CARESCAPE R860 | Nov 4, 2021 | Substantially Equivalent |
| K172702 | Tec 820, Tec 850 | Jan 4, 2018 | Substantially Equivalent |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | Nov 3, 2017 | Substantially Equivalent |
| K170872 | Aisys CS2 | Aug 15, 2017 | Substantially Equivalent |
| K151570 | Carestation 620/650/650C | Jan 21, 2016 | Substantially Equivalent |
| K142679 | CARESCAPE R860 | Jun 12, 2015 | Substantially Equivalent |
| K143530 | Aespire View | Apr 24, 2015 | Substantially Equivalent |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Feb 3, 2015 | Substantially Equivalent |