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 |