The Nellcor pulse oximetry monitor interface cable
FDA 510(k) K172482 · Covidien
510(k) numberK172482
Submission
- Device name
- The Nellcor pulse oximetry monitor interface cable
- Applicant
- Covidien
Boulder, CO, US - Received
- August 16, 2017
- Decision date
- December 15, 2017
- 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 The Nellcor pulse oximetry monitor interface cable cleared by the FDA?
The Nellcor pulse oximetry monitor interface cable (K172482) received a 510(k) decision of Substantially Equivalent on December 15, 2017, 121 days after the submission was received.
What is the product code of K172482?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.