Model SA-1 Stethoscope Audio Amplifier
FDA 510(k) K823126 · Electromedics, Inc.
510(k) numberK823126
Submission
- Device name
- Model SA-1 Stethoscope Audio Amplifier
- Applicant
- Electromedics, Inc.
Mchenry, IL, US - Received
- October 25, 1982
- Decision date
- November 16, 1982
- 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 |
| K800463 | Esophageal StethescopeBZW · Traditional | Medical Components, Inc. | 03/10/1980SE |
More from Medical Components, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K073616 | Fas-Clean Electrosurgical Coated Active BladeGEI · Traditional | 07/23/2008SE |
| K934964 | Electromedics Tympanic Temperature SensorFLL · Traditional | 03/07/1994SE |
| K933832 | Electromedics HG (Hydrogel) Series Skin Temperature SensorFLL · Traditional | 01/28/1994SE |
| K934355 | Electromedics Blood Heat ExchangerDTR · Traditional | 12/03/1993SE |
| K930154 | EL2-SERIES Blood Collection ReervoirDTN · Traditional | 07/01/1993SE |
| K926250 | Electromedics El-Series Cardiotomy ReservoirDTN · Traditional | 02/19/1993SE |
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | 02/05/1993SE |
| K915737 | Autotransfusion Blood Collection ReservoirDTN · Traditional | 09/03/1992SE |
| K910238 | Portable Auto Transfusion System 500CAC · Traditional | 06/19/1991SE |
| K910935 | Modified Pyrogen TestingDTM · Traditional | 05/16/1991SE |
Questions and answers
When was Model SA-1 Stethoscope Audio Amplifier cleared by the FDA?
Model SA-1 Stethoscope Audio Amplifier (K823126) received a 510(k) decision of Substantially Equivalent on November 16, 1982, 22 days after the submission was received.
What is the product code of K823126?
The FDA product code is BZW – Stethoscope, Esophageal, a Class I (low risk) device regulated under 21 CFR 868.1910.