Stethoscope
by Swartz Medical Equipment 3 variants
510(k) K771506
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771506 | Date26 Aug 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1875
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Stethoscope is a mechanical diagnostic device designed to amplify and transmit sounds produced by the heart, blood vessels, lungs, and other internal organs for clinical auscultation. It enables healthcare professionals to evaluate cardiac, respiratory, and vascular function by listening to physiological sounds through a chestpiece and earpieces.
Stethoscopes are typically supplied as reusable, non-sterile devices intended for use in clinical settings such as hospitals, physician offices, and emergency care. They are classified as Class II devices under FDA regulations (21 CFR 870.1875) and require compliance with traditional 510(k) clearance pathways. Multiple model variants are registered, each identified by unique FEI numbers, and are intended for general cardiovascular assessment without specific sterility or MRI safety constraints.
Other devices from Swartz Medical Equipment
Questions
AI-generated answers, 1 Oct 2026
What is the Swartz Stethoscope used for?
The Swartz Stethoscope is designed to amplify and transmit physiological sounds from the heart, blood vessels, lungs, and other internal organs. It helps healthcare professionals evaluate cardiac, respiratory, and vascular function during clinical auscultation. This device is intended for general cardiovascular assessment and is not restricted to specific conditions or MRI-safe environments.
How is the Swartz Stethoscope supplied and intended for use?
The Swartz Stethoscope is supplied as a reusable, non-sterile device. It is intended for use in clinical settings such as hospitals, physician offices, and emergency care. Due to its non-sterile nature, it is not suitable for procedures requiring sterile conditions, such as surgeries or invasive examinations.
Are there different models of the Swartz Stethoscope, and how can I identify them?
Yes, multiple model variants of the Swartz Stethoscope are registered, each identified by unique FEI (Final Establishment Identification) numbers. These include models like 3013557562, 3010399798, and others listed in the regulatory records. The FEI number helps distinguish between different variants, though all share the same core purpose of cardiovascular auscultation.
Does the Swartz Stethoscope require any special storage or maintenance?
As a reusable, non-sterile device, the Swartz Stethoscope should be stored in a clean, dry environment to prevent contamination and damage. Regular cleaning and disinfection between uses are recommended to maintain hygiene and functionality. Follow manufacturer guidelines for proper care to ensure longevity and reliability.
What regulatory pathway does the Swartz Stethoscope follow?
The Swartz Stethoscope is classified as a Class II medical device under FDA regulations (21 CFR 870.1875) and requires compliance with the traditional 510(k) clearance pathway. This pathway ensures that the device meets established safety and effectiveness standards for general cardiovascular auscultation. The device was originally submitted in 1977 and has since undergone FDA review.