DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
FDA 510(k) clearance K033876 · decided 2004-03-11
Clearance details
- K-number
- K033876
- Device name
- DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
- Applicant
- Dolphin Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-15
- Decision date
- 2004-03-11
- Days to decision
- 87 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Highlands Ranch, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.