Model 2900 Metabolic Measurement Cart
FDA 510(k) K915686 · Sensor Medics Corp.
510(k) numberK915686
Submission
- Device name
- Model 2900 Metabolic Measurement Cart
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- December 20, 1991
- Decision date
- December 1, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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Questions and answers
When was Model 2900 Metabolic Measurement Cart cleared by the FDA?
Model 2900 Metabolic Measurement Cart (K915686) received a 510(k) decision of Substantially Equivalent on December 1, 1992, 347 days after the submission was received.
What is the product code of K915686?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.