Argyle Esophageal Stethoscope
FDA 510(k) K790523 · Sherwood Medical Industries
510(k) numberK790523
Submission
- Device name
- Argyle Esophageal Stethoscope
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- March 15, 1979
- Decision date
- March 27, 1979
- 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 |
|---|---|---|---|
| K874519 | Modified Esophageal Stethoscope/Temperature SensorBZW · Traditional | Mon-A-Therm, Inc. | 01/29/1988SE |
| 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 |
More from Electromedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K781060 | Monoject Endosseous Dental ImplantDZE · Traditional | 08/14/1978SE |
| K772149 | Lancer Biopsy HolderKER · Traditional | 11/22/1977SE |
Questions and answers
When was Argyle Esophageal Stethoscope cleared by the FDA?
Argyle Esophageal Stethoscope (K790523) received a 510(k) decision of Substantially Equivalent on March 27, 1979, 12 days after the submission was received.
What is the product code of K790523?
The FDA product code is BZW – Stethoscope, Esophageal, a Class I (low risk) device regulated under 21 CFR 868.1910.