VMAX229 Series Pulmonary/Metabolic Systems
FDA 510(k) K942211 · Sensor Medics Corp.
510(k) numberK942211
Submission
- Device name
- VMAX229 Series Pulmonary/Metabolic Systems
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- May 5, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K173937 | SpiroSphereBTY · Traditional | Eresearchtechnology GmbH | 02/15/2019SE |
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Questions and answers
When was VMAX229 Series Pulmonary/Metabolic Systems cleared by the FDA?
VMAX229 Series Pulmonary/Metabolic Systems (K942211) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 201 days after the submission was received.
What is the product code of K942211?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.