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510(k) K945238

MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 by F. Walter Hanel GmbH — Product Code IWQ

K945238 is an FDA 510(k) premarket notification submitted by F. Walter Hanel GmbH for the device "MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code IWQ (Curtain, Protective, Radiographic), 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
December 15, 1994
Date Received
October 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curtain, Protective, Radiographic
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)
  • K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272 (October 7, 1993)

Other clearances for product code IWQ

  • K923099 — X-RAY DRAPES (October 15, 1992)
  • K873038 — TECHTON PROTECTIVE PAD (April 3, 1989)

FDA data resources