The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Ethox Surgi-cuf Adult Disposable Blood Pressure Cuffs.
| Device ID | K040286 |
| 510k Number | K040286 |
| Device Name: | ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS |
| Classification | Blood Pressure Cuff |
| Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Contact | Eon Verrall |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2004-03-15 |
| Summary: | summary |