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510(k) K894607

PAQ10 PAPER CHART RECORDER by Protocol Systems, Inc. — Product Code DSF

K894607 is an FDA 510(k) premarket notification submitted by Protocol Systems, Inc. for the device "PAQ10 PAPER CHART RECORDER". The FDA issued a decision of Substantially Equivalent on October 26, 1989. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Protocol Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Paper Chart
Device Class
Class I
Regulation Number
870.2810
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 DSF

  • K910871 — EDENTEC DIGITAL CHARTER MODEL 3710 (August 29, 1991)
  • K912929 — DASH IV (August 13, 1991)
  • K905856 — MODEL 556 MONITOR (January 11, 1991)
  • K902586 — GRI LASERGRAPH(TM) ECG PAPER (June 22, 1990)
  • K902230 — COLORADO COLOR IMAGING RECORDER (June 19, 1990)
  • K901385 — GABRIEL MEDICAL CLS THERMAL RECORDER (May 9, 1990)
  • K895111 — TYPE 9541 RECORDER, PAPER CHART (January 26, 1990)
  • K894922 — WR3500 AND WR3600 SERIES RECORDERS (January 26, 1990)
  • K894736 — MT96000 PAPER CHART RECORDER (December 13, 1989)
  • K893561 — EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (August 25, 1989)

FDA data resources