Modified Esophageal Stethoscope/Temperature Sensor
FDA 510(k) K874519 · Mon-A-Therm, Inc.
510(k) numberK874519
Submission
- Device name
- Modified Esophageal Stethoscope/Temperature Sensor
- Applicant
- Mon-A-Therm, Inc.
St. Louis, MO, US - Received
- November 2, 1987
- Decision date
- January 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZW – Stethoscope, Esophageal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.1910
- Specialty
- Anesthesiology
Other 510(k)s with product code BZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860558 | Esophageal StethoscopeBZW · Traditional | Sharn, Inc. | 04/01/1986SE |
| K844444 | Esophageal StethoscopeBZW · Traditional | Medical Parameters, Inc. | 01/10/1985SE |
| K843070 | Esophageal StethoscopesBZW · Traditional | Primrose Medical, Inc. | 08/24/1984SE |
| K842865 | Esophageal StethoscopeBZW · Traditional | Inmed Corp. | 08/15/1984SE |
| K841574 | Quazar Esophageal StethoscopeBZW · Traditional | Axiom Medical, Inc. | 08/15/1984SE |
| K830329 | Esophageal StethoscopeBZW · Traditional | Science Development Corp. | 03/11/1983SE |
| K830218 | Sheridan/Esophageal StethoscopeBZW · Traditional | Sheridan Catheter Corp. | 03/09/1983SE |
| K823703 | Esophageal StethoscopeBZW · Traditional | Rsp, Inc. | 01/07/1983SE |
| K823126 | Model SA-1 Stethoscope Audio AmplifierBZW · Traditional | Electromedics, Inc. | 11/16/1982SE |
| K800463 | Esophageal StethescopeBZW · Traditional | Medical Components, Inc. | 03/10/1980SE |
More from Medical Components, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K885187 | Model 1000 Electronic Clinical ThermometerFLL · Traditional | 03/08/1989SE |
| K874522 | Modified Myocardial Temperature SensorKRB · Traditional | 01/29/1988SE |
| K875234 | Mon-A-Therm's Skin Temperature SensorFLL · Traditional | 01/19/1988SE |
| K874525 | Modified Foley Catheter/Temperature SensorKOD · Traditional | 01/06/1988SE |
| K874524 | Modified Subcutaneous Temperature SensorFLL · Traditional | 01/06/1988SE |
| K874523 | Modified Tympanic & Esophageal/Rectal Temp. SensorFLL · Traditional | 01/06/1988SE |
| K874521 | Modified Thermal Well Temperature SensorFLL · Traditional | 01/06/1988SE |
| K874520 | Modified Airway Temperature SensorFLL · Traditional | 01/06/1988SE |
| K853392 | Mon-A-Therm Subcutaneous Temp. SensorFLL · Traditional | 11/22/1985SE |
| K830819 | Modification Electronic Clinical Thermo-FLL · Traditional | 04/06/1983SE |
Questions and answers
When was Modified Esophageal Stethoscope/Temperature Sensor cleared by the FDA?
Modified Esophageal Stethoscope/Temperature Sensor (K874519) received a 510(k) decision of Substantially Equivalent on January 29, 1988, 88 days after the submission was received.
What is the product code of K874519?
The FDA product code is BZW – Stethoscope, Esophageal, a Class I (low risk) device regulated under 21 CFR 868.1910.