ALGO I— 510(k) K852687

Substantially Equivalent

Algotek, Inc.

FDA 510(k) clearance K852687 for ALGO I, Substantially Equivalent on 1985-09-18. Applicant: Algotek, Inc.. Device class: 2.

Clearance details

Applicant: Algotek, Inc.
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 1985-06-25
Decision date: 1985-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWJ

K242954 — Integrity V500 (Integrity, Integrity with VEMP)2024-12-19
K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)2024-03-08
K220139 — QScreen2022-08-03
K211147 — ALGO 7i2021-10-14
K193033 — GSI Audera Pro2020-04-24

More clearances from Algotek, Inc.

K864408 — EMG-1, MOTOR NERVE MONITOR1987-01-30

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