EASI LEAD SYSTEM CABLE ASSEMBLY— 510(k) K872781

Name: FDA 510(k) clearance K872781
Creator: U.S. Food and Drug Administration
Published: 1987-12-29

Substantially Equivalent

Totemite Medical Electronics

FDA 510(k) clearance K872781 for EASI LEAD SYSTEM CABLE ASSEMBLY, Substantially Equivalent on 1987-12-29. Applicant: Totemite Medical Electronics. Device class: 2.

Clearance details

Applicant: Totemite Medical Electronics
Product code: Code DRW
Device class: Class 2
Regulation: 21 CFR 870.2350
Advisory panel: Cardiovascular
Date received: 1987-07-14
Decision date: 1987-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blaine, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRW

view all

K033513 — EASI ECG ALGORITHM2004-01-15
K020456 — EASI 12 LEAD ALGORITHM2002-07-09
K930786 — EPCOR1994-09-26
K861981 — ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR1986-08-25
K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR1985-11-08

More clearances from Totemite Medical Electronics

view all

K802900 — HEART SENTINEL1981-03-11

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