FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VACUUM POWER BODY FLUID SUCTION APPARATUS
K Number: K926140
·
Decision Jul 27, 1993
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
20
Applicant Total
33
Review Days
232
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Basic Information
- Device Name
- VACUUM POWER BODY FLUID SUCTION APPARATUS
- K Number
- K926140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom, Inc.
- Date Received
- December 7, 1992
- Decision Date
- July 27, 1993
- Product Code
- KDP
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KDP | Regulator, Vacuum | FDA class 2 | General Hospital |
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Other Clearances by Hill-Rom, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | Mar 4, 2021 | Substantially Equivalent |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | May 7, 2018 | Substantially Equivalent |
| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | Nov 16, 2001 | Substantially Equivalent |
| 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 |