The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070.
Device ID | K012989 |
510k Number | K012989 |
Device Name: | DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-06 |
Decision Date | 2002-03-20 |
Summary: | summary |