Sensormedics Model 2450 Pulmonary Function Lab.
FDA 510(k) K915848 · Sensor Medics Corp.
510(k) numberK915848
Submission
- Device name
- Sensormedics Model 2450 Pulmonary Function Lab.
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- December 26, 1991
- Decision date
- October 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sensormedics Model 2450 Pulmonary Function Lab. cleared by the FDA?
Sensormedics Model 2450 Pulmonary Function Lab. (K915848) received a 510(k) decision of Substantially Equivalent on October 28, 1992, 307 days after the submission was received.
What is the product code of K915848?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.