EDENTEC MODEL 2860 PRESSURE METER— 510(k) K891540

Name: FDA 510(k) clearance K891540
Creator: U.S. Food and Drug Administration
Published: 1989-06-01

Substantially Equivalent

Edentec Corp.

FDA 510(k) clearance K891540 for EDENTEC MODEL 2860 PRESSURE METER, Substantially Equivalent on 1989-06-01. Applicant: Edentec Corp.. Device class: 2.

Clearance details

Applicant: Edentec Corp.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1989-03-17
Decision date: 1989-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYE

view all

K160112 — Besmed PEEP Valve2016-04-29
K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE2014-04-14
K133210 — B&B BUBBLER2014-03-28
K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES2013-08-05
K112546 — O_TWO CPAP SYSTEM2011-12-27

More clearances from Edentec Corp.

view all

K953363 — OXIFLOW DIGITAL RECORDER1996-02-06
K953540 — EEE1995-08-25
K921819 — EDENTEC MODEL 3710 I DIGITAL PRINTER1993-10-22
K913749 — EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 31701992-07-02
K910870 — EDENTEC MODEL 3711 DIGITAL RECORDER1991-08-29

Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.