Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software
FDA 510(k) K121806 · Covidien
510(k) numberK121806
Submission
- Device name
- Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software
- Applicant
- Covidien
Boulder, CO, US - Received
- June 20, 2012
- Decision date
- September 28, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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Questions and answers
When was Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software cleared by the FDA?
Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software (K121806) received a 510(k) decision of Substantially Equivalent on September 28, 2012, 100 days after the submission was received.
What is the product code of K121806?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.