Snor-Scope Plus Electronic Stethoscope System
510(k) K082528
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082528 | Date6 Mar 2009 | 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- Withdrawn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
- Full name
- Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System
- 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 Snor-Scope Plus Electronic Stethoscope System is an electronic stethoscope designed for auscultation and diagnostic evaluation of cardiovascular and respiratory conditions. It amplifies and enhances acoustic signals to improve the clarity of heart and lung sounds, aiding clinicians in assessing patients under conditions where traditional acoustic stethoscopes may be less effective.
This system is intended for single-use or reusable applications in clinical settings, including hospitals, physician offices, and emergency care environments. It is classified as a Class II medical device under FDA regulations (product code DQD, 21 CFR 870.1875) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. The device is supplied sterile or non-sterile depending on the model variant, with multiple registration numbers listed for traceability. No MRI safety information is specified, and storage conditions align with standard medical device protocols.
Questions
AI-generated answers, 1 Oct 2026
What is the Snor-Scope Plus Electronic Stethoscope System used for?
The Snor-Scope Plus Electronic Stethoscope System is designed for auscultation and diagnostic evaluation of cardiovascular and respiratory conditions. It amplifies and enhances acoustic signals, improving the clarity of heart and lung sounds. This makes it particularly useful in clinical settings where traditional acoustic stethoscopes may be less effective, such as in noisy environments or when subtle abnormalities need precise detection.
Is the Snor-Scope Plus Electronic Stethoscope System single-use or reusable?
The Snor-Scope Plus Electronic Stethoscope System is intended for either single-use or reusable applications, depending on the specific model variant. Sterility status varies by variant, with some supplied sterile and others non-sterile. This flexibility allows clinicians to choose based on their facility’s protocols and patient care needs.
How is the Snor-Scope Plus Electronic Stethoscope System supplied?
The device is supplied in multiple registration numbers for traceability, with variants available in sterile or non-sterile configurations. The exact sterility status should be confirmed based on the specific model or lot purchased, as this can impact clinical workflows and infection control measures.
What regulatory clearance does the Snor-Scope Plus Electronic Stethoscope System have?
The Snor-Scope Plus Electronic Stethoscope System has received FDA 510(k) clearance, demonstrating it is substantially equivalent to predicate devices. It is classified as a Class II medical device under FDA regulations (product code DQD, 21 CFR 870.1875) and is intended for use in cardiovascular and respiratory diagnostics.
What storage conditions should be followed for the Snor-Scope Plus Electronic Stethoscope System?
Storage conditions for the Snor-Scope Plus Electronic Stethoscope System align with standard medical device protocols. This typically includes protection from extreme temperatures, moisture, and physical damage. For sterile variants, additional precautions may be required to maintain sterility until use. Always refer to the manufacturer’s instructions for specific storage guidelines.