FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3420 DIGIT PULSE OXIMETER, MODEL 3420
K Number: K013171
·
Decision Jan 3, 2002
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
13
Review Days
101
Basic Information
- Device Name
- 3420 DIGIT PULSE OXIMETER, MODEL 3420
- K Number
- K013171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BCI, INC.
- Date Received
- September 24, 2001
- Decision Date
- January 3, 2002
- 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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|---|---|---|---|
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| K944121 | SHARPS CONTAINER 18 GALLON | Jan 27, 1995 | Substantially Equivalent |