FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K Number: K013709
·
Decision Nov 16, 2001
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
97
Applicant Total
33
Review Days
8
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Basic Information
- Device Name
- HILL-ROM PRIMAVIEW MONITOR SYSTEM
- K Number
- K013709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom, Inc.
- Date Received
- November 8, 2001
- Decision Date
- November 16, 2001
- Product Code
- FET
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K973705 | CONTOR TABLE SURFACE | Aug 7, 1998 | 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 |