Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw
FDA 510(k) K130320 · Covidien
510(k) numberK130320
Submission
- Device name
- Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw
- Applicant
- Covidien
Boulder, CO, US - Received
- February 8, 2013
- Decision date
- February 4, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw cleared by the FDA?
Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw (K130320) received a 510(k) decision of Substantially Equivalent on February 4, 2014, 361 days after the submission was received.
What is the product code of K130320?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.