BZW · Stethoscope, Esophageal
Anesthesiology · 21 CFR 868.1910 · Class 1
Overview
| Product Code | BZW |
|---|---|
| Device Name | Stethoscope, Esophageal |
| Regulation | 21 CFR 868.1910 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath 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 § 868.9.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874519 | MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR | Mon-A-Therm, Inc. | Jan 29, 1988 | SESE |
| K860558 | ESOPHAGEAL STETHOSCOPE | Sharn, Inc. | Apr 1, 1986 | SESE |
| K844444 | ESOPHAGEAL STETHOSCOPE | Medical Parameters, Inc. | Jan 10, 1985 | SESE |
| K843070 | ESOPHAGEAL STETHOSCOPES | Primrose Medical, Inc. | Aug 24, 1984 | SESE |
| K842865 | ESOPHAGEAL STETHOSCOPE | Inmed Corp. | Aug 15, 1984 | SESE |
| K841574 | QUAZAR ESOPHAGEAL STETHOSCOPE | Axiom Medical, Inc. | Aug 15, 1984 | SESE |
| K830329 | ESOPHAGEAL STETHOSCOPE | Science Development Corp. | Mar 11, 1983 | SESE |
| K830218 | SHERIDAN/ESOPHAGEAL STETHOSCOPE | Sheridan Catheter Corp. | Mar 9, 1983 | SESE |
| K823703 | ESOPHAGEAL STETHOSCOPE | Rsp, Inc. | Jan 7, 1983 | SESE |
| K823126 | MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER | Electromedics, Inc. | Nov 16, 1982 | SESE |
| K800463 | ESOPHAGEAL STETHESCOPE | Medical Components, Inc. | Mar 10, 1980 | SESE |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Sherwood Medical Industries | Mar 27, 1979 | SESE |
| K771411 | ESOPHAGEAL STETH. TEMP. SENSOR | Labarge, Inc. | Sep 23, 1977 | SESE |
Top Applicants
- Sherwood Medical Industries — 1 clearance
- Sheridan Catheter Corp. — 1 clearance
- Sharn, Inc. — 1 clearance
- Science Development Corp. — 1 clearance
- Rsp, Inc. — 1 clearance
