Skytron Life Island 21
FDA 510(k) K926045 · Skytron, Div. the Kmw Group, Inc.
510(k) numberK926045
Submission
- Device name
- Skytron Life Island 21
- Applicant
- Skytron, Div. the Kmw Group, Inc.
Grand Rapids, MI, US - Received
- December 1, 1992
- Decision date
- July 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FNM – Mattress, Air Flotation, Alternating Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5550
- Specialty
- General Hospital
Other 510(k)s with product code FNM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973169 | Pressure Guard Site Select (a)FNM · Traditional | Span-America Medical Systems, Inc. | 02/20/1998SE |
| K974319 | Mighty AirFNM · Traditional | Wheelchairs of Kansas | 01/22/1998SE |
| K972022 | ZAK-2000FNM · Traditional | Cardio Systems, Inc. | 01/22/1998SE |
| K974070 | PHYSIO/1000FNM · Traditional | Physio Designs, Inc. | 01/06/1998SE |
| K972549 | SimpulseFNM · Traditional | Kinetic Concepts, Inc. | 11/18/1997SE |
| K970081 | Super Air 9000 Alternating Air Floatation Mattress SystemFNM · Traditional | Cathay Consolidated, Inc. | 11/07/1997SE |
| K955243 | BariairFNM · Traditional | Kinetic Concepts, Inc. | 10/23/1997SE |
| K970468 | KT Air BedFNM · Traditional | Kinetic Concepts, Inc. | 09/05/1997SE |
| K965207 | Rid-Decube IIFNM · Traditional | Skin Care Management, Inc. | 08/21/1997SE |
| K972153 | Alternating Pressure Air Flotation MattressFNM · Traditional | Decubiti Concepts, Inc. | 07/31/1997SE |
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| K002463 | StellarFSY · Traditional | 11/08/2000SE |
| K992090 | Millennium GoldFSY · Traditional | 09/08/1999SE |
| K950192 | Skytron Skyboom SeriesFQO · Traditional | 04/03/1995SE |
| K940616 | Skytron Elite 3500 TableGDC · Traditional | 06/13/1994SE |
| K933564 | Skytron Exam LightKZF · Traditional | 02/10/1994SE |
| K915285 | Skytron Infinity Series Surgical LightsFSY · Traditional | 02/20/1992SE |
| K900472 | Skytron Model 860 and 800 Comp. Surgita Neuro EquiHBN · Traditional | 09/04/1990SE |
| K900211 | Skytron Universe Series Surgical LightsFSY · Traditional | 03/19/1990SE |
Questions and answers
When was Skytron Life Island 21 cleared by the FDA?
Skytron Life Island 21 (K926045) received a 510(k) decision of Substantially Equivalent on July 27, 1993, 238 days after the submission was received.
What is the product code of K926045?
The FDA product code is FNM – Mattress, Air Flotation, Alternating Pressure, a Class II (moderate risk) device regulated under 21 CFR 880.5550.