FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SWC/DWC WARMING CABINETS
K Number: K080609
·
Decision Jun 13, 2008
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
23
Applicant Total
1
Review Days
102
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Basic Information
- Device Name
- SWC/DWC WARMING CABINETS
- K Number
- K080609
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5950
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mac Medical
- Date Received
- March 3, 2008
- Decision Date
- June 13, 2008
- Product Code
- LHC
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| LHC | Warmer, Irrigation Solution | FDA class 1 | Physical Medicine |
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