FIBERSCOPIC SCOPE RECORDER SYSTEM— 510(k) K770782

Substantially Equivalent

Elmed, Inc.

FDA 510(k) clearance K770782 for FIBERSCOPIC SCOPE RECORDER SYSTEM, Substantially Equivalent on 1977-05-06. Applicant: Elmed, Inc.. Device class: 2.

Clearance details

Applicant: Elmed, Inc.
Product code: Code GWK
Device class: Class 2
Regulation: 21 CFR 882.1845
Advisory panel: Neurology
Date received: 1977-05-02
Decision date: 1977-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWK

K060919 — ACTICAL2006-09-22
K061870 — VITALSENSE XHR2006-08-31
K052489 — ACTIHEART2005-09-27
K991045 — MINI-LOGGER SERIES 20001999-09-21
K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-43001991-06-28

More clearances from Elmed, Inc.

K010465 — DENSTAT2001-05-14
K974793 — ELMED ESU 120 M/M DIGITAL1998-03-19
K953271 — ELMED RF-ALERT1996-01-18
K952110 — ELMED THERMO-FLUX1995-08-14
K926517 — ELMED LBC 50-P1994-11-15

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