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510(k) K933603

LEADWIRE by Sentry Medical Products, Inc. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1994
Date Received
July 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

Other clearances by Sentry Medical Products, Inc.

  • K962122 — SENTRY RADIOTRANSLUCENT ECG ELECTRODES (July 24, 1996)
  • K955636 — SENTRY DISPOSABLE DISPERSIVE ELECTRODE (March 27, 1996)
  • K942827 — SENTRY INSERTION TRAY (November 2, 1994)
  • K934000 — SENTRY AQUEOUS GEL ECG ELECTRODES (August 30, 1994)
  • K935098 — BABY BOARD (February 15, 1994)
  • K932704 — PATIENT CABLE (December 27, 1993)
  • K881670 — ACCUTEMP PLUS (November 22, 1988)
  • K881343 — DURADERM BUTTERFLY (May 4, 1988)
  • K851522 — DIAGNOSTIC ECG DISPOSABLE ELECTRODE (October 24, 1985)
  • K853552 — SENTRY FLEXIBLE TENS (September 26, 1985)

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