Dolphin Medical, Inc.
Highlands Ranch, CO, US
Dolphin Medical, Inc. appears in FDA device records in Highlands Ranch, CO. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Dolphin Medical, Inc. between 2002 and 2006. The busiest year on record is 2003, with 5. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 4 |
| 2003 | 5 |
| 2004 | 2 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060524 | DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES | DQA | Substantially Equivalent | |
| K040380 | DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 | DQA | Substantially Equivalent | |
| K033876 | DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 | DQA | Substantially Equivalent | |
| K032947 | NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 | DQA | Substantially Equivalent | |
| K031465 | MODEL 2100 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K030629 | DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER | DQA | Substantially Equivalent | |
| K030952 | DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 | DQA | Substantially Equivalent | |
| K024235 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER | DQA | Substantially Equivalent | |
| K014218 | OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' | DQA | Substantially Equivalent | |
| K021959 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 | DQA | Substantially Equivalent | |
| K012989 | DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 | DQA | Substantially Equivalent | |
| K020075 | MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER | DQA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain