FE-34TH, FIBER ESOPHAGOSCOPE— 510(k) K951198

Name: FDA 510(k) clearance K951198
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K951198 for FE-34TH, FIBER ESOPHAGOSCOPE, Substantially Equivalent on 1995-05-30. Applicant: Pentax Precision Instrument Corp.. Device class: 2.

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code GCL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-16
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCL

view all

K951197 — FE-24X, FIBER ESOPHAGOSCOPE1995-05-30
K934510 — 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD1994-02-17
K922086 — BARD BIOPSY FORCEPS1992-10-30

More clearances from Pentax Precision Instrument Corp.

view all

K041395 — EG-3630UR2004-06-09
K041396 — FG-36UX FIBER ULTRASOUND GASTROSCOPE2004-06-09
K041397 — EG-3830UT2004-06-09
K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE2003-08-08
K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE2003-02-11

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