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510(k) K951246

PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS by Protocol Systems, Inc. — Product Code FLS

K951246 is an FDA 510(k) premarket notification submitted by Protocol Systems, Inc. for the device "PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS". The FDA issued a decision of Substantially Equivalent - Subject to Tracking Reg. on Feb 2, 1996. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. Protocol Systems, Inc. has 14 other 510(k) clearances on record.

Clearance Details

Decision
ST (Substantially Equivalent - Subject to Tracking Reg.)
Decision Date
Feb 2, 1996
Date Received
Mar 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Apnea, Facility Use
Device Class
Class II
Regulation Number
868.2377
Review Panel
AN
Submission Type
510(k)

Other clearances by Protocol Systems, Inc.

  • K002725 — MICROPAQ, MODELS 402 AND 404 (Nov 21, 2000)
  • K972121 — ACUITY CENTRAL STATION (Nov 7, 1997)
  • K945071 — PROPAQ 200 MONITOR (May 10, 1995)
  • K935846 — MODEL ACUITY CENTRAL STATION (Dec 5, 1994)
  • K934711 — PROPAQ ECG TELEMETRY OPTION (Sep 1, 1994)
  • K921497 — PROPAQ MONITORS, MODIFICATION (Mar 23, 1993)
  • K914838 — PROPAQ 102,104,106,102EL,104EL,&106EL (Jan 10, 1992)
  • K913193 — MODEL 100 CENTRAL STATION (Oct 16, 1991)
  • K910882 — PROPAQ 102EL, 104EL AND 106EL (May 8, 1991)
  • K910772 — PROPAQ 102, 104 AND 106 (Apr 12, 1991)

Other clearances for product code FLS

  • K011597 — SMARTMONITOR 2, MODEL 4000 (Jan 11, 2002)
  • K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR (Jan 12, 2000)
  • K962865 — REMBRANDT SYSTEM (Oct 25, 1996)
  • K894973 — RESPITRACE PLUS (Oct 30, 1989)
  • K832999 — RESPIRATION MONITOR (Feb 13, 1984)
  • K830778 — MONITORING KIT AMK-1 (Oct 14, 1983)
  • K822077 — RESPIRATION MONITOR TYPE MR-10 (Oct 6, 1982)
  • K821721 — CLINICAL DATA APNEA DETECTOR (Jul 13, 1982)
  • K820943 — SYSTEM I INFANT MONITORING SYS (May 3, 1982)
  • K810153 — VENTILATORY EFFORT MONITOR (Feb 9, 1981)

FDA data resources