HOLTER 2000— 510(k) K990170

Substantially Equivalent

Zymed Medical Instrumentation

FDA 510(k) clearance K990170 for HOLTER 2000, Substantially Equivalent on 1999-04-13. Applicant: Zymed Medical Instrumentation. Device class: 2.

Clearance details

Applicant: Zymed Medical Instrumentation
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1999-01-19
Decision date: 1999-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLO

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More clearances from Zymed Medical Instrumentation

K002004 — ZYBIT2000-09-21
K992197 — MODIFICATION TO ZYMED HOLTER 20001999-07-28
K984089 — ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW1999-02-16
K955015 — ZYMED HOLTER SCANNER MODEL 20101996-03-18
K951370 — ZYMED TELEMETRY SYSTEM; MODEL T80101995-10-06

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