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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 ST on February 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
February 2, 1996
Date Received
March 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

Other clearances by Protocol Systems, Inc.

  • K002725 — MICROPAQ, MODELS 402 AND 404 (November 21, 2000)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
  • K945071 — PROPAQ 200 MONITOR (May 10, 1995)
  • K935846 — MODEL ACUITY CENTRAL STATION (December 5, 1994)
  • K934711 — PROPAQ ECG TELEMETRY OPTION (September 1, 1994)
  • K921497 — PROPAQ MONITORS, MODIFICATION (March 23, 1993)
  • K914838 — PROPAQ 102,104,106,102EL,104EL,&106EL (January 10, 1992)
  • K913193 — MODEL 100 CENTRAL STATION (October 16, 1991)
  • K910882 — PROPAQ 102EL, 104EL AND 106EL (May 8, 1991)
  • K910772 — PROPAQ 102, 104 AND 106 (April 12, 1991)

Other clearances for product code FLS

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

FDA data resources