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510(k) K002248

DINAMAP PRO 1000 MONITOR, MODEL 1000 by Critikon Company, LLC — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2000
Date Received
July 25, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Critikon Company, LLC

  • K000500 — DINAMAP ADVANCED NIBP MODULE (May 26, 2000)
  • K992638 — DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 (February 24, 2000)
  • K982342 — DINAMAP MPS SELECT PORTABLE MONITOR (August 14, 1998)
  • K943709 — DINAMAP PLUS VITAL SIGNS MONOITOR (June 16, 1995)
  • K942700 — DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (March 1, 1995)
  • K933404 — CRITIKON CENTRAL STATIN MONITOR (February 9, 1994)
  • K933050 — CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH (December 14, 1993)
  • K915697 — CRITIKON VITAL SIGNS MODULE (July 1, 1993)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K912188 — DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 (December 4, 1991)

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