FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
K Number: K953472
·
Decision Oct 20, 1995
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
18
Review Days
88
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Basic Information
- Device Name
- NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
- K Number
- K953472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nellcor, Inc.
- Date Received
- July 24, 1995
- Decision Date
- October 20, 1995
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Nellcor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K904039 | REFLECTANCE SENSOR (RS-10) | Dec 27, 1990 | Substantially Equivalent |