FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NELLCOR INDGO MANUAL RESUSCITATOR
K Number: K023494
·
Decision Feb 7, 2003
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
42
Review Days
112
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Basic Information
- Device Name
- NELLCOR INDGO MANUAL RESUSCITATOR
- K Number
- K023494
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nellcor Puritan Bennett, Inc.
- Date Received
- October 18, 2002
- Decision Date
- February 7, 2003
- Product Code
- BTM
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | Dec 13, 2004 | 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 |
| K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 | Sep 24, 2002 | Substantially Equivalent |