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510(k) K934206

MAVIG ANGIO SHIELD MODELS 6290 & 6272 by F. Walter Hanel GmbH — Product Code KPY

K934206 is an FDA 510(k) premarket notification submitted by F. Walter Hanel GmbH for the device "MAVIG ANGIO SHIELD MODELS 6290 & 6272". The FDA issued a decision of Substantially Equivalent on October 7, 1993. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. F. Walter Hanel GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1993
Date Received
August 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by F. Walter Hanel GmbH

  • K954945 — HANEL MAVIG MONITOR SUSPENSION SYSTEM (January 29, 1996)
  • K945238 — MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 626 (December 15, 1994)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954146 — UTK-DTE AUTILARY SHIELD (December 6, 1995)
  • K953610 — AUKULYTE (September 26, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
  • K912378 — DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS (March 18, 1992)
  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)

FDA data resources