FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPO2 OPTION
K Number: K902730
·
Decision Oct 22, 1990
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
15
Review Days
123
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Basic Information
- Device Name
- SPO2 OPTION
- K Number
- K902730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Protocol Systems, Inc.
- Date Received
- June 21, 1990
- Decision Date
- October 22, 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 |
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)
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FDA Class 2
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FDA 510(k)
FDA Class 2
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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
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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 Protocol Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002725 | MICROPAQ, MODELS 402 AND 404 | Nov 21, 2000 | Substantially Equivalent |
| K972121 | ACUITY CENTRAL STATION | Nov 7, 1997 | Substantially Equivalent |
| K951246 | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS | Feb 2, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K945071 | PROPAQ 200 MONITOR | May 10, 1995 | Substantially Equivalent |
| K935846 | MODEL ACUITY CENTRAL STATION | Dec 5, 1994 | Substantially Equivalent |
| K934711 | PROPAQ ECG TELEMETRY OPTION | Sep 1, 1994 | Substantially Equivalent |
| K921497 | PROPAQ MONITORS, MODIFICATION | Mar 23, 1993 | Substantially Equivalent |
| K914838 | PROPAQ 102,104,106,102EL,104EL,&106EL | Jan 10, 1992 | Substantially Equivalent |
| K913193 | MODEL 100 CENTRAL STATION | Oct 16, 1991 | Substantially Equivalent |
| K910882 | PROPAQ 102EL, 104EL AND 106EL | May 8, 1991 | Substantially Equivalent |