FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULMONEX DYNAMIC AIR THERAPY UNIT
K Number: K950756
·
Decision May 30, 1995
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
16
Applicant Total
31
Review Days
102
Basic Information
- Device Name
- PULMONEX DYNAMIC AIR THERAPY UNIT
- K Number
- K950756
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5225
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HILL-ROM, INC.
- Date Received
- February 17, 1995
- Decision Date
- May 30, 1995
- Product Code
- IKZ
- 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 |
|---|---|---|---|
| IKZ | Bed, Patient Rotation, Powered | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| 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 |
| K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) | Apr 3, 1997 | Substantially Equivalent |