3M Littmann Electronic Stethoscope

FDA 510(k) K961848 · Minnesota Mining and Mfg. Co.

Substantially Equivalent

510(k) numberK961848

Submission

Device name
3M Littmann Electronic Stethoscope
Applicant
Minnesota Mining and Mfg. Co.
St. Paul, MN, US
Received
May 13, 1996
Decision date
September 26, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQD – Stethoscope, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1875
Specialty
Cardiovascular

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Questions and answers

When was 3M Littmann Electronic Stethoscope cleared by the FDA?

3M Littmann Electronic Stethoscope (K961848) received a 510(k) decision of Substantially Equivalent on September 26, 1997, 501 days after the submission was received.

What is the product code of K961848?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.