DA VINCHI EMG/EP ISA1004EP— 510(k) K001467

Substantially Equivalent

Airsep Corp.

FDA 510(k) clearance K001467 for DA VINCHI EMG/EP ISA1004EP, Substantially Equivalent on 2000-08-01. Applicant: Airsep Corp.. Device class: 2.

Clearance details

Applicant: Airsep Corp.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2000-05-10
Decision date: 2000-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWE

K221471 — E3 and Profile2022-11-22
K212936 — Vision Monitor- MonCvONE2022-11-21
K211974 — LED PHOTIC System2021-09-23
K211643 — Vision Monitor - MonpackONE2021-07-26
K200705 — Nurochek System2020-04-23

More clearances from Airsep Corp.

K101154 — CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L2011-03-28
K080348 — OXISCAN II DATA MANAGEMENT SYSTEM2008-10-09
K020324 — LIFESTYLE OXYGEN CONCENTRATOR2002-03-13
K012037 — HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS0092002-01-17
K000963 — DA VINCHI EEG AND EMG/EP SYSTEMS2000-10-20

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