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510(k) K921498

VER MED A10011 PNS DUAL ELEMENT ELECTRODE by Vermont Medical, Inc. — Product Code BXM

K921498 is an FDA 510(k) premarket notification submitted by Vermont Medical, Inc. for the device "VER MED A10011 PNS DUAL ELEMENT ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 9, 1993. The device falls under product code BXM (Stimulator, Nerve, Ac-Powered), a Class II device regulated under 21 CFR 868.2775. Vermont Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1993
Date Received
March 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Ac-Powered
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Vermont Medical, Inc.

  • K030073 — VERMED A10021 RESTING EKG TAB ELECTRODE (March 28, 2003)
  • K021537 — MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 (March 3, 2003)
  • K010638 — NEUROPLUS, MODEL A10040, A10041, A10042, A10043 (May 3, 2001)
  • K915831 — THERMAL PROBE COVER (June 8, 1992)
  • K911687 — VER-MED A10020 RESTING EKG ELECTRODE (October 10, 1991)
  • K910139 — VER-MED A10014 RESTING EKG ELECTRODE & A10021 (August 15, 1991)
  • K905489 — VER-MED A10017 UNIVERSAL ELECTRODE (March 21, 1991)
  • K781430 — PREGELLED DISPOSABLE E.K.G. ELECTRODE (October 31, 1978)

Other clearances for product code BXM

  • K013215 — MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (October 16, 2001)
  • K002677 — NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (November 13, 2000)
  • K870662 — MODEL SKCK STERILE KNOB COVER KIT (October 28, 1987)

FDA data resources