The following data is part of a premarket notification filed by Span-america Medical Systems, Inc. with the FDA for Pressureguard Iv.
| Device ID | K972486 |
| 510k Number | K972486 |
| Device Name: | PRESSUREGUARD IV |
| Classification | Bed, Patient Rotation, Powered |
| Applicant | SPAN-AMERICA MEDICAL SYSTEMS, INC. 70 COMMERCE DR. P.O. BOX 5231 Greenville, SC 29615 |
| Contact | Wanda Totton |
| Correspondent | Wanda Totton SPAN-AMERICA MEDICAL SYSTEMS, INC. 70 COMMERCE DR. P.O. BOX 5231 Greenville, SC 29615 |
| Product Code | IKZ |
| CFR Regulation Number | 890.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-02 |
| Decision Date | 1998-02-20 |
| Summary: | summary |