Ibed Wireless with Ibed Awareness
FDA 510(k) K103536 · Stryker Corporation
510(k) numberK103536
Submission
- Device name
- Ibed Wireless with Ibed Awareness
- Applicant
- Stryker Corporation
Portage, MI, US - Received
- December 1, 2010
- Decision date
- December 16, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5100
- Specialty
- General Hospital
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| K974254 | Benefit B3--- SeriesFNL · Traditional | M.C. Healthcare Products, Inc. | 12/16/1997SE |
| K972115 | Volker Hospital Bed, Model K960FNL · Traditional | Volker Healthcare, Inc. | 08/29/1997SE |
| K971546 | Soma 900 Transport BedFNL · Traditional | Nova Technologies, Inc. | 07/10/1997SE |
| K963622 | Vail 2000 Enclosed BedFNL · Traditional | Vail Products, Inc. | 05/07/1997SE |
| K963589 | Vail 3000 Bed EnclosureFNL · Traditional | Vail Products, Inc. | 04/21/1997SE |
| K962942 | TotalcareFNL · Traditional | Hill-Rom, Inc. | 02/03/1997SE |
| K963701 | Soma Safe EnclosureFNL · Traditional | Nova Technology Corp. | 01/24/1997SE |
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Questions and answers
When was Ibed Wireless with Ibed Awareness cleared by the FDA?
Ibed Wireless with Ibed Awareness (K103536) received a 510(k) decision of Substantially Equivalent on December 16, 2010, 15 days after the submission was received.
What is the product code of K103536?
The FDA product code is FNL – Bed, Ac-Powered Adjustable Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5100.