System 3000 Fluidized Air Bed
FDA 510(k) K890935 · Dermanetics Corp.
510(k) numberK890935
Submission
- Device name
- System 3000 Fluidized Air Bed
- Applicant
- Dermanetics Corp.
Long Beach, CA, US - Received
- February 24, 1989
- Decision date
- March 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5170
- Specialty
- Physical Medicine
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|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | Hill-Rom | 03/10/2015SE |
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| K973624 | Nurse's Aid Patient Rotation SystemIOQ · Traditional | Air Med Assist Products | 01/21/1998SE |
| K970364 | AIRTEC2 Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970363 | Hydrotec Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970636 | Totalcare., Modular Therapy System (MTS)IOQ · Traditional | Hill-Rom, Inc. | 08/26/1997SE |
| K964873 | Silkair Low Airloss TherapyIOQ · Traditional | Hill-Rom, Inc. | 07/03/1997SE |
| K970295 | Flexicair Exlipse PlusIOQ · Traditional | Hill-Rom, Inc. | 05/16/1997SE |
| K943433 | Total Contact Seat Ripple SystemIOQ · Traditional | Numotech, Inc. | 07/31/1995SE |
| K951001 | Flexicair ExlipseIOQ · Traditional | Hill-Rom, Inc. | 06/27/1995SE |
More from Hill-Rom, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894723 | System 2500 Medical WaterbedIOQ · Traditional | 08/17/1989SE |
Questions and answers
When was System 3000 Fluidized Air Bed cleared by the FDA?
System 3000 Fluidized Air Bed (K890935) received a 510(k) decision of Substantially Equivalent on March 15, 1989, 19 days after the submission was received.
What is the product code of K890935?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.