TCPM II TOURNIQUET CUFF PRESSURE MONITOR— 510(k) K900104

Name: FDA 510(k) clearance K900104
Creator: U.S. Food and Drug Administration
Published: 1990-03-15

Substantially Equivalent

Electromedics, Inc.

FDA 510(k) clearance K900104 for TCPM II TOURNIQUET CUFF PRESSURE MONITOR, Substantially Equivalent on 1990-03-15. Applicant: Electromedics, Inc.. Device class: 1.

Clearance details

Applicant: Electromedics, Inc.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 1990-01-09
Decision date: 1990-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCY

view all

K202919 — ATS 5000 Automatic Tourniquet Instrument2021-05-20
K162365 — T-Cuff2017-02-16
K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM2013-08-09
K112874 — EZ VEIN INFLATABLE TOURNIQUET2011-10-17
K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C0700022007-06-07

More clearances from Electromedics, Inc.

view all

K934964 — ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR1994-03-07
K933832 — ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR1994-01-28
K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER1993-12-03
K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR1993-07-01
K926250 — ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR1993-02-19

Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.