AMER. BENTLEY HEMOFILTER HOLDER HFH-1— 510(k) K843504

Name: FDA 510(k) clearance K843504
Creator: U.S. Food and Drug Administration
Published: 1984-10-18

Substantially Equivalent

American Bentley

FDA 510(k) clearance K843504 for AMER. BENTLEY HEMOFILTER HOLDER HFH-1, Substantially Equivalent on 1984-10-18. Applicant: American Bentley. Device class: 2.

Clearance details

Applicant: American Bentley
Product code: Code FKI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1984-09-06
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FKI

view all

K811292 — PARALLEL PLATE DIALYZER HOLDER1981-06-02
K802075 — HOLLOW FIBER DIALYZER HOLDER1980-09-16

More clearances from American Bentley

view all

K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-1001988-02-12
K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER1987-11-06
K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-1001987-09-01
K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-35001987-09-01
K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS1987-08-24

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