The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Modification To Osi Medical Dolphin Stand-alone Pulse Oximeter.
| Device ID | K020075 |
| 510k Number | K020075 |
| Device Name: | MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER |
| 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 | 2002-01-09 |
| Decision Date | 2002-02-08 |
| Summary: | summary |