FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hill-Rom Wireless Connectivity Module
K Number: K143414
·
Decision Mar 10, 2015
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
2
Review Days
102
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Basic Information
- Device Name
- Hill-Rom Wireless Connectivity Module
- K Number
- K143414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom
- Date Received
- November 28, 2014
- Decision Date
- March 10, 2015
- Product Code
- IOQ
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Hill-Rom
| K Number | Device Name | ||
|---|---|---|---|
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | Jun 3, 2013 | Substantially Equivalent |