The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Akrotech 4000t Kinetic Turning Low Air Loss System.
| Device ID | K962123 |
| 510k Number | K962123 |
| Device Name: | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Contact | Joe Z Anetti |
| Correspondent | Joe Z Anetti LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1996-07-18 |
| Summary: | summary |