BZS · Stethoscope Head
Anesthesiology · 21 CFR 868.1930 · Class 1
Overview
| Product Code | BZS |
|---|---|
| Device Name | Stethoscope Head |
| Regulation | 21 CFR 868.1930 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935146 | DISPOSABLE STETHOSCOPE HEAD COVER | Modern Medical Devices, Inc. | Jul 11, 1994 | SESE |
| K930118 | STETSKINS | Nova Diversified Concepts | Mar 26, 1993 | SESE |
| K801050 | SUPRA SCOPE | Warner-Lambert Co. | May 14, 1980 | SESE |
Top Applicants
- Warner-Lambert Co. — 1 clearance
- Nova Diversified Concepts — 1 clearance
- Modern Medical Devices, Inc. — 1 clearance
