The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin 2000 Datex Compatible Oximetry Disposable And Reusable Sensors And Extension Cables.
Device ID | K060524 |
510k Number | K060524 |
Device Name: | DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES |
Classification | Oximeter |
Applicant | DOLPHIN MEDICAL INC. 9433 S. MORNING GLORY LN. Highlands Ranch, CO 80130 |
Contact | Bill Curnan |
Correspondent | Bill Curnan DOLPHIN MEDICAL INC. 9433 S. MORNING GLORY LN. Highlands Ranch, CO 80130 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-27 |
Decision Date | 2006-06-15 |
Summary: | summary |