LDE · Stethoscope, Manual
Cardiovascular · 21 CFR 870.1875 · Class 1
Overview
| Product Code | LDE |
|---|---|
| Device Name | Stethoscope, Manual |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.
Classification Rationale
Manual stethoscope: 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 § 870.9. Electronic stethoscope: Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945082 | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | Cypress Medical Products, Ltd. | Dec 8, 1994 | SESE |
| K944337 | VARIOUS STETHOSCOPES | Rud Riester GmbH & CO KG | Nov 30, 1994 | SESE |
| K940578 | MANUAL STETOSCOPE | Bhs Intl., Inc. | Apr 26, 1994 | SESE |
| K935944 | PROSCOPES AND ADSCOPES | American Diagnostic Corp. | Mar 3, 1994 | SESE |
| K923327 | STETHOSCOPE COVER | Anup Chakraborty Co. | Nov 3, 1992 | SESE |
| K924095 | TIMEOSCOPE AND FLEXISCOPE | Stethoscopes of America, Inc. | Oct 20, 1992 | SESE |
| K914100 | STETHOSCOPE | Atlas Medical Products, Inc. | Nov 7, 1991 | SESE |
| K912128 | MAXI-SCOPE OR ULTRA-SCOPE | Seiichi Mfg., Inc. | Jun 28, 1991 | SESE |
| K905487 | VARIOUS TYPES OF STETHOSCOPES | Liaoning-Usa Corp. | Apr 9, 1991 | SESE |
| K904547 | STETHOSCOPE | Kimball Industries Co., Ltd. | Mar 21, 1991 | SESE |
| K895545 | V*S*R(TM) SCOPE | Vsr Enterprises Corp. | Nov 15, 1989 | SESE |
| K890126 | KAMED STETHOSCOPE | D.R.G. | Apr 21, 1989 | SESE |
| K882324 | STETH-SHIELD ACCESSORY TO A STETHOSCOPE | Steth-Shield, Inc. | Jul 18, 1988 | SESE |
| K871369 | VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: | Keeler Instruments, Inc. | Sep 24, 1987 | SESE |
| K860473 | DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE | Schering Corp. | Aug 14, 1986 | SESE |
| K854771 | SALTZMAN STETHOSCOPE HEAD | K & S Medicorp | May 9, 1986 | SESE |
| K843324 | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH | Cher Mel Corp. | Jun 6, 1985 | SESE |
| K842203 | LITTMAN TYPE SH-6010, NURSE TYPE | Cher Mel Corp. | Jun 6, 1985 | SESE |
| K830796 | THE BLOOM STETHOSCOPE | Stethophonics, Inc. | Jul 19, 1983 | SESE |
| K821909 | LITTMAN TUNABLE STETHOSCOPE 2136 | 3M Company | Jul 14, 1982 | SESE |
Top Applicants
- Conphar, Inc. — 3 clearances
- Cher Mel Corp. — 2 clearances
- 3M Company — 1 clearance
- Abco Dealers, Inc. — 1 clearance
- American Diagnostic Corp. — 1 clearance
