Home / 510(k) Clearances / K864745

510(k) K864745

POET OXIMETER by Criticare Systems, Inc. — Product Code DQE

K864745 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "POET OXIMETER". The FDA issued a decision of Substantially Equivalent on June 2, 1987. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Criticare Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1987
Date Received
December 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Oximeter, Fiber-Optic
Device Class
Class II
Regulation Number
870.1230
Review Panel
CV
Submission Type

Other clearances by Criticare Systems, Inc.

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • K091050 — 506CN PATIENT MONITOR (May 27, 2009)
  • K042569 — 8600 VITAL SIGNS MONITOR (September 29, 2004)
  • K030613 — VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 (April 17, 2003)
  • K022435 — 507EL VITAL SIGNS MONITOR (August 14, 2002)
  • K012059 — 8100/8500 VITAL SIGNS MONITOR (August 1, 2001)
  • K001020 — 8100 VITAL SIGNS MONITOR (April 28, 2000)
  • K000276 — MPT 24 AND VITAL VIEW 24 (March 1, 2000)
  • K961223 — MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS (December 10, 1996)
  • K944860 — SCHOLAR PATIENT MONITOR (June 20, 1995)

Other clearances for product code DQE

  • K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Ce (February 20, 2018)
  • K160645 — PreSep Oligon Oximetry Catheter (June 16, 2016)
  • K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHET (July 2, 2014)
  • K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (February 18, 2011)
  • K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (September 18, 2009)
  • K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (November 3, 2006)
  • K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (October 5, 2006)
  • K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE C (August 4, 2006)
  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (June 26, 2006)
  • K060093 — PRESEP OLIGON OXIMETRY CATHETERS (April 28, 2006)

FDA data resources