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 |