DIRECT WRITING VECTORCARDIOGRAPH— 510(k) K810529

Substantially Equivalent

Elmed, Inc.

FDA 510(k) clearance K810529 for DIRECT WRITING VECTORCARDIOGRAPH, Substantially Equivalent on 1981-04-23. Applicant: Elmed, Inc.. Device class: 2.

Clearance details

Applicant: Elmed, Inc.
Product code: Code DYC
Device class: Class 2
Regulation: 21 CFR 870.2400
Advisory panel: Cardiovascular
Date received: 1981-02-26
Decision date: 1981-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYC

K023414 — MIDA ALGORITHM REV. B2003-12-05
K896396 — MIDA SYSTEM, MODELS 1000/11001990-01-18
K823934 — CARIEL F121983-12-16

More clearances from Elmed, Inc.

K010465 — DENSTAT2001-05-14
K974793 — ELMED ESU 120 M/M DIGITAL1998-03-19
K953271 — ELMED RF-ALERT1996-01-18
K952110 — ELMED THERMO-FLUX1995-08-14
K926517 — ELMED LBC 50-P1994-11-15

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