Product Code: SFO
FDA class 2
21 CFR 862.1120
Electrode Measurement, Drain Effluent Ph
Clinical Chemistry
510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SFO
- Device Class
- FDA class 2
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Measurement of drain effluent pH
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243965 | Origin | Aug 21, 2025 | Substantially Equivalent | Nerv Technology Inc. (D.B.A.) Fluidai Medical |