The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 And 2422.
Device ID | K033876 |
510k Number | K033876 |
Device Name: | DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 |
Classification | Oximeter |
Applicant | DOLPHIN MEDICAL INC. 9433 S. MORNING GLORY LN. Littleton, CO 80130 |
Contact | Bill Curnan |
Correspondent | Bill Curnan DOLPHIN MEDICAL INC. 9433 S. MORNING GLORY LN. Littleton, 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 | 2003-12-15 |
Decision Date | 2004-03-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859998006156 | K033876 | 000 |