IQSense Flow Sensor Mouthpiece
FDA 510(k) K150515 · Sdi Diagnostics, Inc.
510(k) numberK150515
Submission
- Device name
- IQSense Flow Sensor Mouthpiece
- Applicant
- Sdi Diagnostics, Inc.
Easton, MA, US - Received
- March 2, 2015
- Decision date
- January 12, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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Questions and answers
When was IQSense Flow Sensor Mouthpiece cleared by the FDA?
IQSense Flow Sensor Mouthpiece (K150515) received a 510(k) decision of Substantially Equivalent on January 12, 2016, 316 days after the submission was received.
What is the product code of K150515?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.