FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NELLCOR PORTABLE PULSE OXIMETER MODEL N-20
K Number: K915699
·
Decision May 27, 1993
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
18
Review Days
521
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NELLCOR PORTABLE PULSE OXIMETER MODEL N-20
- K Number
- K915699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nellcor, Inc.
- Date Received
- December 23, 1991
- Decision Date
- May 27, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
FDA 510(k)
FDA Class 2
·Cardiovascular
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Pulse Oximeter (SP61)
FDA 510(k)
FDA Class 2
·Cardiovascular
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K913695 | NELLCOR(R) N-180 PULSE OXIMETER | Nov 13, 1991 | Substantially Equivalent |
| K904039 | REFLECTANCE SENSOR (RS-10) | Dec 27, 1990 | Substantially Equivalent |