Quazar Esophageal Stethoscope
FDA 510(k) K841574 · Axiom Medical, Inc.
510(k) numberK841574
Submission
- Device name
- Quazar Esophageal Stethoscope
- Applicant
- Axiom Medical, Inc.
Mchenry, IL, US - Received
- April 17, 1984
- Decision date
- August 15, 1984
- 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 |
| 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 |
|---|---|---|
| K993592 | Axiom Multipurpose Wound DrainBSO · Traditional | 05/17/2000SE |
| K971851 | Interpleural Anesthesia CatheterBSO · Traditional | 01/22/1998SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | 03/10/1997SE |
| K934895 | Glassman Silicone CatheterEZL · Traditional | 10/13/1994SE |
| K922760 | Atraum Wound Dressing--ModificationKMF · Traditional | 10/30/1992SE |
| K905422 | PVC Round Wound DrainsGBX · Traditional | 02/11/1991SE |
| K904218 | Suction SystemGEA · Traditional | 10/31/1990SE |
| K904133 | Disposable Fluid Collection BagGBX · Traditional | 10/11/1990SE |
| K863247 | Axiom Trocar Thoracic CatheterGBS · Traditional | 08/29/1986SE |
| K861306 | Suction SystemGEA · Traditional | 06/09/1986SE |
Questions and answers
When was Quazar Esophageal Stethoscope cleared by the FDA?
Quazar Esophageal Stethoscope (K841574) received a 510(k) decision of Substantially Equivalent on August 15, 1984, 120 days after the submission was received.
What is the product code of K841574?
The FDA product code is BZW – Stethoscope, Esophageal, a Class I (low risk) device regulated under 21 CFR 868.1910.