Sensormedics Model 2130 Spieometry System
FDA 510(k) K920111 · Sensor Medics Corp.
510(k) numberK920111
Submission
- Device name
- Sensormedics Model 2130 Spieometry System
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- January 10, 1992
- Decision date
- October 26, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Sensormedics Model 2130 Spieometry System cleared by the FDA?
Sensormedics Model 2130 Spieometry System (K920111) received a 510(k) decision of Substantially Equivalent on October 26, 1992, 290 days after the submission was received.
What is the product code of K920111?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.