ECHOSAMPLER— 510(k) K041237

Substantially Equivalent

Gynetics Medical Products NV

FDA 510(k) clearance K041237 for ECHOSAMPLER, Substantially Equivalent on 2004-09-08. Applicant: Gynetics Medical Products NV. Device class: 2.

Clearance details

Applicant: Gynetics Medical Products NV
Product code: Code HFF
Device class: Class 2
Regulation: 21 CFR 884.1060
Advisory panel: Obstetrics/Gynecology
Date received: 2004-05-11
Decision date: 2004-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HFF

K903002 — PROBET (TM)1991-04-05
K902693 — WALLACH FLEXIBLE ENDOMETRIAL SAMPLER1991-01-31
K831212 — ENDOSCANN1984-06-15
K820641 — ACCURETTE1982-06-22

More clearances from Gynetics Medical Products NV

K013501 — IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B2001-11-30
K013536 — EMTRAC; DELPHIN; SEMTRAC 2000 SET2001-11-30
K013497 — FAS SET #45512001-11-09

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