FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTOR TABLE SURFACE
K Number: K973705
·
Decision Aug 7, 1998
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
33
Review Days
312
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Basic Information
- Device Name
- CONTOR TABLE SURFACE
- K Number
- K973705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom, Inc.
- Date Received
- September 29, 1997
- Decision Date
- August 7, 1998
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | Nov 16, 2001 | Substantially Equivalent |
| K981081 | BRIGHTSTAR | Apr 29, 1998 | Substantially Equivalent |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | Feb 2, 1998 | Substantially Equivalent |
| K971366 | INCUWARMER | Jan 5, 1998 | Substantially Equivalent |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Aug 26, 1997 | Substantially Equivalent |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | Jul 3, 1997 | Substantially Equivalent |
| K964223 | CLINITRON RITE-HITE | May 28, 1997 | Substantially Equivalent |
| K970295 | FLEXICAIR EXLIPSE PLUS | May 16, 1997 | Substantially Equivalent |