PULMOTRACK,MODEL 1010— 510(k) K980878

Name: FDA 510(k) clearance K980878
Creator: U.S. Food and Drug Administration
Published: 1998-12-28

Substantially Equivalent

Karmel Medical Acoustic Technologies , Ltd.

FDA 510(k) clearance K980878 for PULMOTRACK,MODEL 1010, Substantially Equivalent on 1998-12-28. Applicant: Karmel Medical Acoustic Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Karmel Medical Acoustic Technologies , Ltd.
Product code: Code BZM
Device class: Class 2
Regulation: 21 CFR 868.1900
Advisory panel: Anesthesiology
Date received: 1998-03-09
Decision date: 1998-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZM

view all

K102229 — PULMOTRACK 2020 SYSTEM2011-03-04
K090863 — PERSONAL WHEEZOMETER2009-09-21
K071955 — WIM-PC, MODEL 10102007-11-01
K012387 — STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM2002-04-23
K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM1998-07-21

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