FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENFLOW IV FLUID WARMER
K Number: K112902
·
Decision Mar 14, 2012
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
74
Applicant Total
75
Review Days
162
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Basic Information
- Device Name
- ENFLOW IV FLUID WARMER
- K Number
- K112902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vital Signs, Inc.
- Date Received
- October 4, 2011
- Decision Date
- March 14, 2012
- Product Code
- LGZ
- 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 |
|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | FDA class 2 | General Hospital |
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| K000441 | BODYGUARD | Apr 11, 2000 | Substantially Equivalent |
| K994044 | CLEEN-ABLE | Feb 25, 2000 | Substantially Equivalent |
| K990412 | CUFF-ABLE PLUS | Sep 1, 1999 | Substantially Equivalent |
| K984468 | VITAL PEP | Jun 1, 1999 | Substantially Equivalent |