The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin Medical 2150 Handheld Pulse Oximeter.
| Device ID | K030629 |
| 510k Number | K030629 |
| Device Name: | DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER |
| 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 | 2003-02-27 |
| Decision Date | 2003-09-04 |
| Summary: | summary |