FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UROSURGE UROTHERM FLUID WARMING SYSTEM
K Number: K965136
·
Decision Oct 16, 1998
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
23
Applicant Total
4
Review Days
662
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Basic Information
- Device Name
- UROSURGE UROTHERM FLUID WARMING SYSTEM
- K Number
- K965136
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5950
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton Regulatory Assoc.
- Date Received
- December 23, 1996
- Decision Date
- October 16, 1998
- 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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