ENTERSCAN— 510(k) K874081

Substantially Equivalent

Pie Data Medical BV

FDA 510(k) clearance K874081 for ENTERSCAN, Substantially Equivalent on 1987-12-31. Applicant: Pie Data Medical BV. Device class: 2.

Clearance details

Applicant: Pie Data Medical BV
Product code: Code LWI
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1987-10-07
Decision date: 1987-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht 6227 Aj, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code LWI

K960421 — SINUSCAN 102/SINUSPRINT1997-04-16
K960044 — ULTRAMAX/MODEL NUMBER A11996-08-02
K960241 — CPR GENERAL SURGERY TRAY1996-03-22

More clearances from Pie Data Medical BV

K874192 — MULTIPURPOSE TRANSDUCER RANGE1988-07-19
K870058 — PIE MEDICAL SCANNER 10001988-02-02
K870653 — ULTRASOUND LINEAR/SECTOR SCANNER 11001988-02-02
K871082 — FETAL CARE MONITOR ANTEPARTUM 15001987-08-04

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