| Device Classification Name |
Mattress, Air Flotation, Alternating Pressure
|
| 510(k) Number |
K942920 |
| Device Name |
MEDAIR EXCEL 2000 |
| Applicant |
| Medifloat, Inc. |
| 123 Orchard St., Suite 1a |
|
Ormond Beach,
FL
32174
|
|
| Applicant Contact |
D. RAY STINSON |
| Correspondent |
| Medifloat, Inc. |
| 123 Orchard St., Suite 1a |
|
Ormond Beach,
FL
32174
|
|
| Correspondent Contact |
D. RAY STINSON |
| Regulation Number | 880.5550 |
| Classification Product Code |
|
| Date Received | 06/21/1994 |
| Decision Date | 09/19/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|