QMED SYSTEM 2150— 510(k) K861437

Substantially Equivalent

Qmed, Inc.

FDA 510(k) clearance K861437 for QMED SYSTEM 2150, Substantially Equivalent on 1986-05-20. Applicant: Qmed, Inc.. Device class: 2.

Clearance details

Applicant: Qmed, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1986-04-17
Decision date: 1986-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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More clearances from Qmed, Inc.

K972991 — MONITOR ONE NDX1998-12-03
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K897121 — QEKG ELECTROCARDIOGRAPH1990-04-30
K873591 — A.R.M. (ASPEN RETURN MONITOR)1987-09-30

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