Ergomat 8000 System
FDA 510(k) K952092 · Ergo-Air, Inc.
510(k) numberK952092
Submission
- Device name
- Ergomat 8000 System
- Applicant
- Ergo-Air, Inc.
Westbury, NY, US - Received
- May 3, 1995
- Decision date
- July 26, 1995
- 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 |
More from Decubiti Concepts, Inc.
Questions and answers
When was Ergomat 8000 System cleared by the FDA?
Ergomat 8000 System (K952092) received a 510(k) decision of Substantially Equivalent on July 26, 1995, 84 days after the submission was received.
What is the product code of K952092?
The FDA product code is FNM – Mattress, Air Flotation, Alternating Pressure, a Class II (moderate risk) device regulated under 21 CFR 880.5550.