The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin 2000 Datex Compatible Oximetry Disposable And Reusable Sensors And Extension Cables.
| Device ID | K060524 |
| 510k Number | K060524 |
| Device Name: | DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-06-15 |
| Summary: | summary |