FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
K Number: K060524
·
Decision Jun 15, 2006
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
12
Review Days
108
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Basic Information
- Device Name
- DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
- K Number
- K060524
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dolphin Medical, Inc.
- Date Received
- February 27, 2006
- Decision Date
- June 15, 2006
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by Dolphin Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040380 | DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 | Aug 31, 2004 | Substantially Equivalent |
| K033876 | DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 | Mar 11, 2004 | Substantially Equivalent |
| K032947 | NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 | Oct 17, 2003 | Substantially Equivalent |
| K031465 | MODEL 2100 PULSE OXIMETER | Oct 10, 2003 | Substantially Equivalent |
| K030629 | DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER | Sep 4, 2003 | Substantially Equivalent |
| K030952 | DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 | May 19, 2003 | Substantially Equivalent |
| K024235 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER | Mar 17, 2003 | Substantially Equivalent |
| K014218 | OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' | Nov 7, 2002 | Substantially Equivalent |
| K021959 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 | Jul 11, 2002 | Substantially Equivalent |
| K012989 | DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 | Mar 20, 2002 | Substantially Equivalent |