The following data is part of a premarket notification filed by Dolphin Medical Inc. with the FDA for Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421.
| Device ID | K030952 |
| 510k Number | K030952 |
| Device Name: | DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 |
| 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 | 2003-03-26 |
| Decision Date | 2003-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859998006293 | K030952 | 000 |
| 00859998006453 | K030952 | 000 |
| 00859998006460 | K030952 | 000 |
| 00859998006477 | K030952 | 000 |
| 00859998006484 | K030952 | 000 |
| 00859998006491 | K030952 | 000 |
| 00859998006507 | K030952 | 000 |
| 00859998006071 | K030952 | 000 |
| 00859998006200 | K030952 | 000 |
| 00859998006217 | K030952 | 000 |
| 00859998006224 | K030952 | 000 |
| 00859998006231 | K030952 | 000 |
| 00859998006248 | K030952 | 000 |
| 00859998006255 | K030952 | 000 |
| 00859998006262 | K030952 | 000 |
| 00859998006279 | K030952 | 000 |
| 00859998006286 | K030952 | 000 |
| 00859998006439 | K030952 | 000 |