Stethoscope Head
The Stethoscope Head is the acoustically sensitive chest piece of a stethoscope, used to auscultate heart, lung, and bowel sounds by directly contacting the patient's body surface; in anesthesiology it is commonly used for intraoperative monitoring of breath sounds. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BZS, regulated under 21 CFR 868.1930 in the Anesthesiology specialty.
Research product code BZS in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- BZS
- Device Class
- FDA class 1
- Regulation Number
- 868.1930
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935146 | DISPOSABLE STETHOSCOPE HEAD COVER | Jul 11, 1994 | Substantially Equivalent | Modern Medical Devices, Inc. |
| K930118 | STETSKINS | Mar 26, 1993 | Substantially Equivalent | Nova Diversified Concepts |
| K801050 | SUPRA SCOPE | May 14, 1980 | Substantially Equivalent | Warner-Lambert Co. |
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.