FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM
K Number: K921528
·
Decision Apr 20, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
33
Review Days
18
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM
- K Number
- K921528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3725
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hill-Rom, Inc.
- Date Received
- April 2, 1992
- Decision Date
- April 20, 1992
- Product Code
- IQA
- 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 |
|---|---|---|---|
| IQA | System, Environmental Control, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IQA), ordered by most recent decision date.
DELTATALKER WITH INFRARED
FDA 510(k)
FDA Class 2
·Physical Medicine
IMPERIUM
FDA 510(k)
FDA Class 2
·Physical Medicine
LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
DEUCE
FDA 510(k)
FDA Class 2
·Physical Medicine
SCANNING DIRECTOR
FDA 510(k)
FDA Class 2
·Physical Medicine
BEDSIDE BUTLER
FDA 510(k)
FDA Class 2
·Physical Medicine
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 |