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510(k) K884320

PROPAQ 106(TM) by Protocol Systems, Inc. — Product Code DRT

K884320 is an FDA 510(k) premarket notification submitted by Protocol Systems, Inc. for the device "PROPAQ 106(TM)". The FDA issued a decision of Substantially Equivalent on December 27, 1988. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Protocol Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1988
Date Received
October 13, 1988
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)
  • K910882 — PROPAQ 102EL, 104EL AND 106EL (May 8, 1991)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • 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)

FDA data resources