FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REFLECTANCE SENSOR (RS-10)
K Number: K904039
·
Decision Dec 27, 1990
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
18
Review Days
114
Basic Information
- Device Name
- REFLECTANCE SENSOR (RS-10)
- K Number
- K904039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- NELLCOR, INC.
- Date Received
- September 4, 1990
- Decision Date
- December 27, 1990
- 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 NELLCOR, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K953472 | NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR | Oct 20, 1995 | Substantially Equivalent |
| K952316 | NELLCOR SYMPHONY N-3000 PULSE OXIMETER | Aug 17, 1995 | Substantially Equivalent |
| K952222 | NELLCOR N-20PA PORTABLE PULSE OXIMETER | Aug 15, 1995 | Substantially Equivalent |
| K942347 | NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 | May 12, 1995 | Substantially Equivalent |
| K945947 | NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER | Mar 8, 1995 | Substantially Equivalent |
| K944760 | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | Oct 17, 1994 | Substantially Equivalent |
| K944400 | PEDI-CAP | Sep 27, 1994 | Substantially Equivalent |
| K915494 | NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 | Aug 6, 1993 | Substantially Equivalent |
| K915699 | NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 | May 27, 1993 | Substantially Equivalent |
| K913695 | NELLCOR(R) N-180 PULSE OXIMETER | Nov 13, 1991 | Substantially Equivalent |