AMER. EDWARDS LAB FLEXISCOPE— 510(k) K842410

Name: FDA 510(k) clearance K842410
Creator: U.S. Food and Drug Administration
Published: 1984-11-05

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K842410 for AMER. EDWARDS LAB FLEXISCOPE, Substantially Equivalent on 1984-11-05. Applicant: American Edwards Laboratories. Device class: 1.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code HRK
Device class: Class 1
Regulation: 21 CFR 886.4855
Advisory panel: Ophthalmic
Date received: 1984-06-19
Decision date: 1984-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRK

view all

K760697 — EVANS ARM AND HAND REST1976-11-02

More clearances from American Edwards Laboratories

view all

K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER1987-12-03
K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F301987-09-30
K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-21987-09-15
K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP1987-04-17
K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP1987-02-27

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