3M Littmann Electronic Stethoscope Model 3000
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K041934 FDA 510(k)
- FDA Product Code
- DQD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1875 FDA 510(k)
- Regulation Number
- 870.1875 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3M Littmann Electronic Stethoscope Model 3000 is an electronic stethoscope designed for auscultation. This device features ambient noise reduction technology to assist in the detection of cardiovascular sounds.
This device is regulated as a Class 2 medical device under FDA 510K authorization. It is manufactured by the 3M Company and is covered by a two-year warranty against defects in material and manufacture.
Frequently asked questions
What is the primary purpose of the 3M Littmann Electronic Stethoscope Model 3000?
This device is designed for auscultation, specifically incorporating ambient noise reduction technology to assist clinicians in the detection of cardiovascular sounds.
Is the Model 3000 covered by a manufacturer warranty?
Yes, the 3M Company provides a two-year warranty for this stethoscope, which covers defects in both material and manufacture.
How is this device classified for regulatory purposes?
The 3M Littmann Electronic Stethoscope Model 3000 is regulated as a Class 2 medical device and has received FDA 510K authorization under the cardiovascular advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Electronic Stethoscope, Littmann Electronic Stethoscope 3000 User Manual | Manualzz, 3M LITTMANN 3000 MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041934 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K041934 24 fields · synced Sep 22, 2026