Product Code: SFP
FDA class 2
21 CFR 868.5630
Ventilator-Compatible Nebulizer
Anesthesiology
510(k)s
2
FEI Numbers
5
Registration Numbers
5
Unique Applicants
2
Years Active
1
Basic Information
- Product Code
- SFP
- Device Class
- FDA class 2
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
The device is intended to deliver nebulized medications through a ventilator breathing circuit.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.