Microair by Invacare Model Apm Alternating Pressure Air Flotation Matress
FDA 510(k) K960411 · Invacare Corp.
510(k) numberK960411
Submission
- Device name
- Microair by Invacare Model Apm Alternating Pressure Air Flotation Matress
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- January 29, 1996
- Decision date
- March 18, 1996
- 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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Questions and answers
When was Microair by Invacare Model Apm Alternating Pressure Air Flotation Matress cleared by the FDA?
Microair by Invacare Model Apm Alternating Pressure Air Flotation Matress (K960411) received a 510(k) decision of Substantially Equivalent on March 18, 1996, 49 days after the submission was received.
What is the product code of K960411?
The FDA product code is FNM – Mattress, Air Flotation, Alternating Pressure, a Class II (moderate risk) device regulated under 21 CFR 880.5550.