The following data is part of a premarket notification filed by Apex Metal, Inc. with the FDA for Airtec2 Low Air Loss Therapy Bed.
Device ID | K970364 |
510k Number | K970364 |
Device Name: | AIRTEC2 LOW AIR LOSS THERAPY BED |
Classification | Bed, Flotation Therapy, Powered |
Applicant | APEX METAL, INC. P.O. BOX 1026 Mt. Pleasant, SC 29465 -1026 |
Contact | Jean Rozint |
Correspondent | Jean Rozint APEX METAL, INC. P.O. BOX 1026 Mt. Pleasant, SC 29465 -1026 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-31 |
Decision Date | 1997-11-17 |