MULTILAB 2000— 510(k) K904392

Substantially Equivalent

Unetixs, Inc.

FDA 510(k) clearance K904392 for MULTILAB 2000, Substantially Equivalent on 1991-04-29. Applicant: Unetixs, Inc.. Device class: 2.

Clearance details

Applicant: Unetixs, Inc.
Product code: Code JAF
Device class: Class 2
Regulation: 21 CFR 892.1540
Advisory panel: Radiology
Date received: 1990-09-24
Decision date: 1991-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K904392

K-number listed on FDA's recall record

Z-1193-2023 — MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01Class II·Ongoing·Unetixs Vascular, Inc.·20230210
Z-1194-2023 — MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01Class II·Ongoing·Unetixs Vascular, Inc.·20230210
Z-1195-2023 — MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01Class II·Ongoing·Unetixs Vascular, Inc.·20230210
Z-1196-2023 — MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01Class II·Ongoing·Unetixs Vascular, Inc.·20230210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904392.

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