Static and Dynamic Compliance, a Respiratory Mechanics Option for the Vmax Series
FDA 510(k) K981366 · Sensor Medics Corp.
510(k) numberK981366
Submission
- Device name
- Static and Dynamic Compliance, a Respiratory Mechanics Option for the Vmax Series
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- April 15, 1998
- Decision date
- October 30, 1998
- 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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Questions and answers
When was Static and Dynamic Compliance, a Respiratory Mechanics Option for the Vmax Series cleared by the FDA?
Static and Dynamic Compliance, a Respiratory Mechanics Option for the Vmax Series (K981366) received a 510(k) decision of Substantially Equivalent on October 30, 1998, 198 days after the submission was received.
What is the product code of K981366?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.