The following data is part of a premarket notification filed by Span-america Medical Systems, Inc. with the FDA for Pressureguard: Low Air Loss Mattress System.
| Device ID | K960620 |
| 510k Number | K960620 |
| Device Name: | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | SPAN-AMERICA MEDICAL SYSTEMS, INC. P.O. BOX 5231 Greenville, SC 29606 |
| Contact | Charles B Mitchell |
| Correspondent | Charles B Mitchell SPAN-AMERICA MEDICAL SYSTEMS, INC. P.O. BOX 5231 Greenville, SC 29606 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-13 |
| Decision Date | 1996-04-25 |
| Summary: | summary |