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510(k) K801549

MODEL R11 SINGLE CHANNEL CHART RECORDER by Medasonics, Inc. — Product Code DSF

K801549 is an FDA 510(k) premarket notification submitted by Medasonics, Inc. for the device "MODEL R11 SINGLE CHANNEL CHART RECORDER". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Medasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
July 7, 1980
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 Medasonics, Inc.

  • K991441 — CADENCE DOPPLER ULTRASOUND SYSTEM (December 28, 1999)
  • K962796 — NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM (January 21, 1997)
  • K961116 — FIRST BEAT/CARDIO BEAT/CALC (August 8, 1996)
  • K914862 — CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS (December 3, 1992)
  • K911453 — OBTRASOUND STETHOSCOPE FETAL CALC (June 20, 1991)
  • K882018 — MEDACORD PVL, PERSONAL VASCULAR LABORATORY (September 21, 1988)
  • K872292 — TRANSPECT TRANSCRANIAL DOPPLER (August 14, 1987)
  • K854734 — MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE (February 10, 1986)
  • K833588 — VASCULAR LABORATORY TREADMILL VT1 (November 14, 1983)
  • K837481 — BF24 DOPPLER MODEL P872 AND P874 (June 24, 1983)

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)
  • K894607 — PAQ10 PAPER CHART RECORDER (October 26, 1989)

FDA data resources