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510(k) K910029

PATIENT CARE MANAGEMENT SYSTEM MODIFICATION by Spacelabs, Inc. — Product Code DXK

K910029 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "PATIENT CARE MANAGEMENT SYSTEM MODIFICATION". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
January 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
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)
  • K896903 — FIRST MEDIC MODEL 510 (December 27, 1990)
  • K904318 — LOCAL REPORT GENERATOR (December 18, 1990)

Other clearances for product code DXK

  • K181042 — Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (May 17, 2018)
  • K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz Intr (February 26, 2016)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K913209 — ACCESSORY TO GENESIS III (GCFM) (May 15, 1992)
  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)
  • K904832 — MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (April 22, 1991)
  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)
  • K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW (February 25, 1991)
  • K904975 — VISTA VIEWING STATION (February 25, 1991)

FDA data resources