FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K Number: K936182
·
Decision Mar 25, 1994
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
36
Applicant Total
120
Review Days
88
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Basic Information
- Device Name
- CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
- K Number
- K936182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1915
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ohmeda Medical
- Date Received
- December 27, 1993
- Decision Date
- March 25, 1994
- Product Code
- KRB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| KRB | Probe, Thermodilution | FDA class 2 | Cardiovascular |
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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 |