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510(k) K896903

FIRST MEDIC MODEL 510 by Spacelabs, Inc. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1990
Date Received
December 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

Other clearances by Spacelabs, Inc.

  • K954962 — SPACELABS MEDICAL MULTIGAS ANALYZER (May 31, 1996)
  • K951605 — SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (July 14, 1995)
  • K950779 — HEART RATE VARIABILITY SOFTWARE OPTION (April 25, 1995)
  • K941165 — COMET CAPNOGRAPH MODULE (October 6, 1994)
  • K923788 — SPACE LABS MODEL 90560 (December 6, 1993)
  • K912742 — ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE (April 20, 1992)
  • K913038 — SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (October 4, 1991)
  • K905065 — DEFIBRILLATOR LEAD ADAPTER (April 12, 1991)
  • K910029 — PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (January 31, 1991)
  • K904318 — LOCAL REPORT GENERATOR (December 18, 1990)

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)