3M Littmann Telesteth Online Ausculation System
FDA 510(k) K120704 · 3M Company
510(k) numberK120704
Submission
- Device name
- 3M Littmann Telesteth Online Ausculation System
- Applicant
- 3M Company
St. Paul, MN, US - Received
- March 8, 2012
- Decision date
- May 3, 2012
- 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 3M Littmann Telesteth Online Ausculation System cleared by the FDA?
3M Littmann Telesteth Online Ausculation System (K120704) received a 510(k) decision of Substantially Equivalent on May 3, 2012, 56 days after the submission was received.
What is the product code of K120704?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.