OLDELFT DIGIDELCA— 510(k) K980296

Name: FDA 510(k) clearance K980296
Creator: U.S. Food and Drug Administration
Published: 1998-04-17

Substantially Equivalent

Oldelft Corp. of America

FDA 510(k) clearance K980296 for OLDELFT DIGIDELCA, Substantially Equivalent on 1998-04-17. Applicant: Oldelft Corp. of America. Device class: 2.

Clearance details

Applicant: Oldelft Corp. of America
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1998-01-27
Decision date: 1998-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPR

view all

K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Oldelft Corp. of America

view all

K973219 — AMBER DU1997-10-08
K946128 — SIMULIX-HP1995-05-12
K950037 — N 800 HF1995-02-15
K932848 — SIMULIX-MC CT EXTENSION1994-03-22
K923584 — THERAPAX DXT 300 SERIES 31993-01-15

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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