The following data is part of a premarket notification filed by Ethox International with the FDA for Surgi-cuf Reusable, Rs Series.
| Device ID | K061962 |
| 510k Number | K061962 |
| Device Name: | SURGI-CUF REUSABLE, RS SERIES |
| Classification | Blood Pressure Cuff |
| Applicant | ETHOX INTERNATIONAL 251 SENECA ST. Buffalo, NY 14204 |
| Contact | John Riggi |
| Correspondent | Neil E Devine, Jr. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-12 |
| Decision Date | 2006-07-25 |
| Summary: | summary |