Surveyor S4 Mobile Monitor
FDA 510(k) K141020 · Mortara Instrument, Inc.
510(k) numberK141020
Submission
- Device name
- Surveyor S4 Mobile Monitor
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- April 21, 2014
- Decision date
- December 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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Questions and answers
When was Surveyor S4 Mobile Monitor cleared by the FDA?
Surveyor S4 Mobile Monitor (K141020) received a 510(k) decision of Substantially Equivalent on December 3, 2014, 226 days after the submission was received.
What is the product code of K141020?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.