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510(k) K830468

MODEL 200 by Western Laboratories Corp. — Product Code FTZ

K830468 is an FDA 510(k) premarket notification submitted by Western Laboratories Corp. for the device "MODEL 200". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FTZ (Locator, Magnetic), a Class I device regulated under 21 CFR 886.4445. Western Laboratories Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
February 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Magnetic
Device Class
Class I
Regulation Number
886.4445
Review Panel
OP
Submission Type

Other clearances by Western Laboratories Corp.

  • K834024 — HEPARINOMETER (June 11, 1984)
  • K821834 — MODEL 100 BICARBONATE CONDUCTIVITY (July 2, 1982)
  • K821414 — MODEL 80 BC (May 27, 1982)
  • K821415 — MODEL 90 BC (May 27, 1982)
  • K801303 — MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST (July 28, 1980)
  • K780932 — MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (August 31, 1978)

Other clearances for product code FTZ

  • K833229 — SUN BED BY VERRE ET QUARTZ UVA-FRANCE (January 27, 1984)

FDA data resources