FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BELMONT BUDDY LITE FLUID WARMER
K Number: K090508
·
Decision Mar 26, 2009
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
13
Applicant Total
20
Review Days
28
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Basic Information
- Device Name
- THE BELMONT BUDDY LITE FLUID WARMER
- K Number
- K090508
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.9205
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Belmont Instrument Corp.
- Date Received
- February 26, 2009
- Decision Date
- March 26, 2009
- Product Code
- BSB
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | FDA class 2 | Hematology |
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Other Clearances by Belmont Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K131519 | BELMONT HYPERTHERMIA PUMP | Nov 6, 2013 | Substantially Equivalent |
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | Nov 16, 2011 | Substantially Equivalent |
| K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 | Jul 1, 2009 | Substantially Equivalent |
| K090089 | BELMONT HYPERTHERMIA PUMP | Feb 12, 2009 | Substantially Equivalent |
| K070654 | HYPERTHERMIA PUMP | Jun 8, 2007 | Substantially Equivalent |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | Oct 19, 2006 | Substantially Equivalent |
| K052547 | BELMONT BUDDY FLUID WARMER | Oct 13, 2005 | Substantially Equivalent |
| K032778 | LARGE VOLUME FLUID RESERVOIR | Sep 22, 2003 | Substantially Equivalent |
| K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | Sep 16, 2003 | Substantially Equivalent |
| K031478 | MICROHEATER | Jul 2, 2003 | Substantially Equivalent |