ESOPHAGEAL STETHOSCOPES— 510(k) K843070

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K843070 for ESOPHAGEAL STETHOSCOPES, Substantially Equivalent on 1984-08-24. Applicant: Primrose Medical, Inc.. Device class: 1.

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code BZW
Device class: Class 1
Regulation: 21 CFR 868.1910
Advisory panel: Anesthesiology
Date received: 1984-08-06
Decision date: 1984-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZW

K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR1988-01-29
K860558 — ESOPHAGEAL STETHOSCOPE1986-04-01
K844444 — ESOPHAGEAL STETHOSCOPE1985-01-10
K841574 — QUAZAR ESOPHAGEAL STETHOSCOPE1984-08-15
K842865 — ESOPHAGEAL STETHOSCOPE1984-08-15

More clearances from Primrose Medical, Inc.

K884711 — URETHRAL AND URETERAL BALLOON DILATATORS1989-09-29
K884713 — COLONIC BALLOON DIALATORS1989-09-29
K884714 — BILIARY DIALATOR1989-09-29
K884715 — ACHELASIA BALLOON DIALATOR1989-09-29
K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)1989-09-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.