The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Cuf-cover (tm).
| Device ID | K031195 |
| 510k Number | K031195 |
| Device Name: | CUF-COVER (TM) |
| Classification | Blood Pressure Cuff |
| Applicant | ETHOX CORP. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ETHOX CORP. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-16 |
| Decision Date | 2003-10-10 |
| Summary: | summary |