FLUIDAIR
FDA 510(k) clearance K881917 · decided 1988-11-14
Clearance details
- K-number
- K881917
- Device name
- FLUIDAIR
- Applicant
- Kinetic Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-09
- Decision date
- 1988-11-14
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- INX
- Device class
- 2
- Regulation number
- 890.5160
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HOME CARE BEAD BED (K972176) | Kinetic Concepts, Inc. | 1998-01-16 |
| CLINITRON RITE-HITE (K964223) | Hill-Rom, Inc. | 1997-05-28 |
| CLINITRON ELEXIS (K943385) | Ssi Medical Services, Inc. | 1995-02-27 |
| CLINITRON AT HOME AIR FLUIDED THERAPY (K942184) | Ssi Medical Services, Inc. | 1995-02-07 |
| X-20 AIR SUPPORT BED (K931168) | American Life Support Technology, Inc. | 1994-02-17 |
| LOW AIR LOSS MATTRESS, MODIFICATION (K934689) | Cardio Systems, Inc. | 1994-02-02 |
| DYLNAMEDICS A.S.A.P. (K924973) | Dynamedics, Inc. | 1993-10-15 |
| COMFORT CARE LOW AIR LOSS THERAPY BED (K926402) | Ch Administration, Inc. | 1993-03-24 |
| REM-AIR (K924686) | Mellenair Ent., Inc. | 1993-02-12 |
| CLINITRON C-II (K920112) | Support Systems Intl. | 1992-01-24 |
| SMITH AND DAVIS PRESSURE THERAPY SYSTEM (K913654) | Smith & Davis Mfg. Co. | 1991-11-22 |
| THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (K911246) | The Medical Group, Inc. | 1991-06-06 |
Recalls involving this device
No recalls on record reference this clearance.