ALARM USED W/MONITORING SPIROMETER— 510(k) K792573

Name: FDA 510(k) clearance K792573
Creator: U.S. Food and Drug Administration
Published: 1979-12-31

Substantially Equivalent

Empire Plastics Manufacturer

FDA 510(k) clearance K792573 for ALARM USED W/MONITORING SPIROMETER, Substantially Equivalent on 1979-12-31. Applicant: Empire Plastics Manufacturer. Device class: 2.

Clearance details

Applicant: Empire Plastics Manufacturer
Product code: Code BZK
Device class: Class 2
Regulation: 21 CFR 868.1850
Advisory panel: Anesthesiology
Date received: 1979-12-13
Decision date: 1979-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZK

view all

K192584 — BEACON Caresystem Model 000021442019-12-18
K192595 — ExSpiron 2Xi2019-12-17
K180788 — Gas Module 32018-10-24
K173181 — ExSpiron 1Xi2018-03-16
K162131 — ExSpiron 1Xi2017-05-09

More clearances from Empire Plastics Manufacturer

view all

K792571 — COUNTER UNIT1979-12-19
K792572 — EMPIRE SPIROMETER1979-12-19
K790744 — LUNG FUNCTION AMPLIFIER EXERCISER1979-04-27

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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