The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210.
| Device ID | K032947 |
| 510k Number | K032947 |
| Device Name: | NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 |
| Classification | Oximeter |
| Applicant | DOLPHIN MEDICAL INC. 9433 S. MORNING GLORY LN. Littleton, CO 80130 |
| Contact | Bill Curnan |
| Correspondent | Bill Curnan DOLPHIN MEDICAL INC. 9433 S. MORNING GLORY LN. Littleton, 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 | 2003-09-22 |
| Decision Date | 2003-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859998006446 | K032947 | 000 |