FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
K Number: K033998
·
Decision Mar 19, 2004
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
28
Review Days
86
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Basic Information
- Device Name
- MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
- K Number
- K033998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Masimo Corp.
- Date Received
- December 24, 2003
- Decision Date
- March 19, 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 |
| K040214 | MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Feb 25, 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 |
| K032551 | MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR | 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 |