Pediatric Hospital Bed
FDA 510(k) K881843 · The Medical Group, Inc.
510(k) numberK881843
Submission
- Device name
- Pediatric Hospital Bed
- Applicant
- The Medical Group, Inc.
Buena Park, CA, US - Received
- May 2, 1988
- Decision date
- October 26, 1988
- 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
Other 510(k)s with product code IOQ
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|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | Hill-Rom | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | Hill-Rom | 06/03/2013SE |
| 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 |
|---|---|---|
| K911246 | The Mediscus Pedcare Management System-Model 2INX · Traditional | 06/06/1991SE |
| K901295 | Pulmonair 40 Patient Management SystemIOQ · Traditional | 03/30/1990SE |
| K881844 | Magnum 800(TM) Management SystemFNL · Traditional | 07/14/1988SE |
| K870284 | Triangular Bandage · Traditional | 02/24/1987SE |
| K870283 | 3 X 3 Sponges, Non-SterileNAB · Traditional | 02/24/1987SE |
| K870282 | 4 X 4 Sponges, Non-SterileNAB · Traditional | 02/24/1987SE |
| K870285 | Thermometer Sheathes, Sterile (Glass)FLK · Traditional | 02/12/1987SE |
| K863769 | Evacuator TipsEHZ · Traditional | 10/30/1986SE |
| K863767 | Glass Mouth Mirrors, ReusableEAX · Traditional | 10/30/1986SE |
| K863766 | Disposable Mouth Mirrors, Single Use OnlyEAX · Traditional | 10/30/1986SE |
Questions and answers
When was Pediatric Hospital Bed cleared by the FDA?
Pediatric Hospital Bed (K881843) received a 510(k) decision of Substantially Equivalent on October 26, 1988, 177 days after the submission was received.
What is the product code of K881843?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.