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 |