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510(k) K882085

PROPAQ 104(TM) by Protocol Systems, Inc. — Product Code DSK

K882085 is an FDA 510(k) premarket notification submitted by Protocol Systems, Inc. for the device "PROPAQ 104(TM)". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Protocol Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
May 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
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 DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)

FDA data resources