Esophageal Stethoscopes
FDA 510(k) K843070 · Primrose Medical, Inc.
510(k) numberK843070
Submission
- Device name
- Esophageal Stethoscopes
- Applicant
- Primrose Medical, Inc.
Mchenry, IL, US - Received
- August 6, 1984
- Decision date
- August 24, 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 |
| 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 |
|---|---|---|
| K884715 | Achelasia Balloon DialatorKNQ · Traditional | 09/29/1989SE |
| K884714 | Biliary DialatorFGE · Traditional | 09/29/1989SE |
| K884713 | Colonic Balloon DialatorsFFP · Traditional | 09/29/1989SE |
| K884711 | Urethral and Ureteral Balloon DilatatorsEZN · Traditional | 09/29/1989SE |
| K884712 | Esophageal and Pyloric Balloon DialatorsKNQ · Traditional | 09/08/1989SE |
| K884709 | Endoscopes & Access.(Sclerotherapy/Transbronchial)ODD · Traditional | 09/08/1989SE |
| K883420 | Lancet, BloodFMK · Traditional | 08/26/1988SE |
| K881976 | Catheter, IntravascularFOZ · Traditional | 08/04/1988SE |
| K881977 | Pressure InfusorKZD · Traditional | 07/29/1988SE |
| K881975 | Set, IntravascularFPA · Traditional | 07/29/1988SE |
Questions and answers
When was Esophageal Stethoscopes cleared by the FDA?
Esophageal Stethoscopes (K843070) received a 510(k) decision of Substantially Equivalent on August 24, 1984, 18 days after the submission was received.
What is the product code of K843070?
The FDA product code is BZW – Stethoscope, Esophageal, a Class I (low risk) device regulated under 21 CFR 868.1910.