The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420.
| Device ID | K040380 |
| 510k Number | K040380 |
| Device Name: | DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 |
| Classification | Oximeter |
| Applicant | DOLPHIN MEDICAL INC. 14240 N. 42ND STREET APT 205 Tampa, FL 33613 |
| Contact | Jon Werner |
| Correspondent | Jon Werner DOLPHIN MEDICAL INC. 14240 N. 42ND STREET APT 205 Tampa, FL 33613 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-08-31 |
| Summary: | summary |