STAND ALONE CYSTOMETROGRAM— 510(k) K934141

Name: FDA 510(k) clearance K934141
Creator: U.S. Food and Drug Administration
Published: 1993-11-18

Substantially Equivalent

Medical Engineering Corp.

FDA 510(k) clearance K934141 for STAND ALONE CYSTOMETROGRAM, Substantially Equivalent on 1993-11-18. Applicant: Medical Engineering Corp.. Device class: 2.

Clearance details

Applicant: Medical Engineering Corp.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-25
Decision date: 1993-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FEN

view all

K212830 — CT3000Pro2021-12-21
K082701 — URONIRS, MODEL 20002008-12-18
K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY2008-03-05
K001386 — ACCUSET SENSOR, MODEL 20002000-07-17
K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E01012000-02-28

More clearances from Medical Engineering Corp.

view all

K905289 — SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT1991-03-13
K903448 — SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER1991-01-14
K902773 — SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET1990-07-16
K884746 — SURGITEK FLAT T-SPAN1989-08-10
K883274 — SURGITEK (R) UROFLOW SYSTEM1989-02-08

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