FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
K Number: K033973
·
Decision Dec 13, 2004
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
42
Review Days
357
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Basic Information
- Device Name
- OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
- K Number
- K033973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nellcor Puritan Bennett, Inc.
- Date Received
- December 22, 2003
- Decision Date
- December 13, 2004
- Product Code
- NLF
- 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 |
|---|---|---|---|
| NLF | Oximeter, Reprocessed | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
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FDA Class 2
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Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
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RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
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Other Clearances by Nellcor Puritan Bennett, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070408 | DURAMAX REUSABLE OXIMETRY SENSOR | May 25, 2007 | Substantially Equivalent |
| K060576 | NELLCOR OXIMAX N-600X PULSE OXIMETER | Aug 14, 2006 | Substantially Equivalent |
| K051271 | OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR | Jan 10, 2006 | Substantially Equivalent |
| K052186 | NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P | Nov 10, 2005 | Substantially Equivalent |
| K051352 | OXIMAX NPB-40 HANDHELD PULSE OXIMETER | Aug 11, 2005 | Substantially Equivalent |
| K050072 | GOODKNIGHT 425ST | Jun 13, 2005 | Substantially Equivalent |
| K030787 | SHILEY FLEXTRA TRACHEOSTOMY TUBE | Nov 14, 2003 | Substantially Equivalent |
| K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N | May 23, 2003 | Substantially Equivalent |
| K023494 | NELLCOR INDGO MANUAL RESUSCITATOR | Feb 7, 2003 | Substantially Equivalent |
| K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 | Sep 24, 2002 | Substantially Equivalent |