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510(k) K800843

MEDEFIZZ A & MEDEFIZZ B by Medefield Pty. , Ltd. — Product Code KTA

K800843 is an FDA 510(k) premarket notification submitted by Medefield Pty. , Ltd. for the device "MEDEFIZZ A & MEDEFIZZ B". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code KTA (Medium, Contrast, Radiologic), a Class U device. Medefield Pty. , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
April 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medium, Contrast, Radiologic
Device Class
Class U
Regulation Number
Review Panel
RA
Submission Type

Other clearances by Medefield Pty. , Ltd.

  • K800840 — MEDEFOAM-2 (June 17, 1980)
  • K800842 — MEDEBAR XAC-90 (May 30, 1980)
  • K800844 — MEDEBAR XL (May 30, 1980)
  • K800841 — MEDEBAR M (May 30, 1980)
  • K800839 — MEDESCAN (May 30, 1980)

Other clearances for product code KTA

  • K800840 — MEDEFOAM-2 (June 17, 1980)
  • K800842 — MEDEBAR XAC-90 (May 30, 1980)
  • K800844 — MEDEBAR XL (May 30, 1980)
  • K800459 — BARIUM SULFATE, USP IN SUSPENSION (May 30, 1980)
  • K800839 — MEDESCAN (May 30, 1980)
  • K800841 — MEDEBAR M (May 30, 1980)
  • K760736 — BARIMEX, BARIUM SULFATE COMPOUND (November 9, 1976)

FDA data resources