ACTIWARE-PLMS— 510(k) K011430

Substantially Equivalent

Mini-Mitter Co., Inc.

FDA 510(k) clearance K011430 for ACTIWARE-PLMS, Substantially Equivalent on 2001-05-31. Applicant: Mini-Mitter Co., Inc.. Device class: 2.

Clearance details

Applicant: Mini-Mitter Co., Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-05-09
Decision date: 2001-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Bend, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWQ

K261604 — Enobio Dx (3 models)2026-06-13
K260455 — New Wave System2026-03-13
K233403 — Flexset System2024-04-30
K231366 — Neuronaute Plus2023-11-09
K221959 — Q212023-08-31

More clearances from Mini-Mitter Co., Inc.

K033534 — VITALSENSE2004-04-22
K991045 — MINI-LOGGER SERIES 20001999-09-21
K991033 — ACTIWATCH-SCORE1999-06-23
K983533 — ACTIWATCH1999-03-23

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