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510(k) K831117

MICROMAT W/VARIOUS MODELS by Pmt, Inc. — Product Code FNW

K831117 is an FDA 510(k) premarket notification submitted by Pmt, Inc. for the device "MICROMAT W/VARIOUS MODELS". The FDA issued a decision of Substantially Equivalent on May 30, 1984. The device falls under product code FNW (Pad, Kelly), a Class II device regulated under 21 CFR 878.4370. Pmt, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1984
Date Received
April 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Kelly
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

Other clearances by Pmt, Inc.

  • K122376 — PMT TRUSCAN SURFACE ELECTRODE (December 19, 2012)
  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K082474 — PMT SUBDURAL CORTICAL ELECTRODES (May 8, 2009)
  • K042901 — ENDOMARK STERILE INDIA INK (March 16, 2005)
  • K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES (August 3, 2004)
  • K972597 — PMT NEW BEGINNINGS GELSHAPES & AMEND (October 1, 1997)
  • K970418 — PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) (April 29, 1997)
  • K964224 — STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTR (March 19, 1997)
  • K935560 — PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) (November 7, 1994)
  • K933079 — ELECTROCAUTERY SYSTEM MODEL 1980 (February 22, 1994)

Other clearances for product code FNW

  • K841183 — SODIUM CHLORIDE SOLUTION BLOOD CELL (May 21, 1984)

FDA data resources