MAVIG ANGIO SHIELD MODELS 6290 & 6272— 510(k) K934206

Name: FDA 510(k) clearance K934206
Creator: U.S. Food and Drug Administration
Published: 1993-10-07

Substantially Equivalent

F. Walter Hanel GmbH

FDA 510(k) clearance K934206 for MAVIG ANGIO SHIELD MODELS 6290 & 6272, Substantially Equivalent on 1993-10-07. Applicant: F. Walter Hanel GmbH. Device class: 1.

Clearance details

Applicant: F. Walter Hanel GmbH
Product code: Code KPY
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1993-08-30
Decision date: 1993-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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K962622 — INTRA-ORAL THERMOPLASTIC SHIELD1996-10-01
K954456 — THERMOPLASTIC SHIELD1995-12-21
K954146 — UTK-DTE AUTILARY SHIELD1995-12-06
K953610 — AUKULYTE1995-09-26

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Recalls naming K934206

K-number listed on FDA's recall record

Z-2962-2018 — Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765Class II·Terminated·Bayer Medical Care, Inc.·20180628

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934206.

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