FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
K Number: K915848
·
Decision Oct 28, 1992
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
31
Applicant Total
26
Review Days
307
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Basic Information
- Device Name
- SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
- K Number
- K915848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sensor Medics Corp.
- Date Received
- December 26, 1991
- Decision Date
- October 28, 1992
- Product Code
- DZJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | FDA class 2 | Dental |
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| K991972 | INFANT FLOW SYSTEM | Aug 13, 1999 | Substantially Equivalent |
| K984254 | INFANT FLOW NCPAP MASKS | Feb 24, 1999 | Substantially Equivalent |