Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M
FDA 510(k) K061112 · Conmed Corporation
510(k) numberK061112
Submission
- Device name
- Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- April 21, 2006
- Decision date
- May 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M cleared by the FDA?
Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M (K061112) received a 510(k) decision of Substantially Equivalent on May 22, 2006, 31 days after the submission was received.
What is the product code of K061112?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.