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510(k) K910882

PROPAQ 102EL, 104EL AND 106EL by Protocol Systems, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1991
Date Received
March 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Protocol Systems, Inc.

  • K002725 — MICROPAQ, MODELS 402 AND 404 (November 21, 2000)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
  • K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY O (February 2, 1996)
  • 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)
  • K910772 — PROPAQ 102, 104 AND 106 (April 12, 1991)

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  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)