FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINITRON C-10
K Number: K914351
·
Decision Feb 14, 1992
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
26
Applicant Total
6
Review Days
140
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Basic Information
- Device Name
- CLINITRON C-10
- K Number
- K914351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ssi Medical Services, Inc.
- Date Received
- September 27, 1991
- Decision Date
- February 14, 1992
- Product Code
- IXQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | FDA class 2 | Radiology |
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Other Clearances by Ssi Medical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943385 | CLINITRON ELEXIS | Feb 27, 1995 | Substantially Equivalent |
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY | Feb 7, 1995 | Substantially Equivalent |
| K890523 | SUPERCAIR | Feb 10, 1989 | Substantially Equivalent |
| K882161 | ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM | Jul 12, 1988 | Substantially Equivalent |
| K863047 | FLEXICAIR | Sep 5, 1986 | Substantially Equivalent |