The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin Medical Stand-alone Pulse Oximeter, Model 2100.
| Device ID | K021959 |
| 510k Number | K021959 |
| Device Name: | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 |
| Classification | Oximeter |
| Applicant | DOLPHIN MEDICAL INC. 13801 MCCORMICK DR. Tampa, FL 33626 |
| Contact | Jon Werner |
| Correspondent | Jon Werner DOLPHIN MEDICAL INC. 13801 MCCORMICK DR. Tampa, FL 33626 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-14 |
| Decision Date | 2002-07-11 |
| Summary: | summary |