FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL T11 FLUIDOTHERAPY UNIT
K Number: K896817
·
Decision Jan 18, 1991
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
44
Review Days
410
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Basic Information
- Device Name
- MODEL T11 FLUIDOTHERAPY UNIT
- K Number
- K896817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Henley Intl.
- Date Received
- December 4, 1989
- Decision Date
- January 18, 1991
- Product Code
- LSB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| LSB | Unit, Fluidotherapy | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LSB), ordered by most recent decision date.
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