FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K Number: K040214
·
Decision Feb 25, 2004
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
28
Review Days
26
Basic Information
- Device Name
- MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K Number
- K040214
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MASIMO CORP.
- Date Received
- January 30, 2004
- Decision Date
- February 25, 2004
- 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 MASIMO CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K041815 | LNCS OXIMETRY SENSORS | Jul 29, 2004 | Substantially Equivalent |
| K041204 | NC SP02 ADAPTER CABLE | Jun 29, 2004 | Substantially Equivalent |
| K040259 | MASIMO SET INTELLIVUE PULSE OXIMETER MODULE | Apr 22, 2004 | Substantially Equivalent |
| K033998 | MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V | Mar 19, 2004 | Substantially Equivalent |
| K032551 | MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR | Feb 19, 2004 | Substantially Equivalent |
| K033296 | MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V | Feb 19, 2004 | Substantially Equivalent |
| K033349 | AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 | Jan 28, 2004 | Substantially Equivalent |
| K033298 | SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS | Dec 12, 2003 | Substantially Equivalent |
| K031330 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | May 12, 2003 | Substantially Equivalent |
| K013792 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Dec 11, 2001 | Substantially Equivalent |