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510(k) K780245

RECORDER, RE-100P HOT STYLUS STRIP CHART by Waters Assoc., Inc. — Product Code DSF

K780245 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "RECORDER, RE-100P HOT STYLUS STRIP CHART". The FDA issued a decision of Substantially Equivalent on March 27, 1978. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1978
Date Received
February 13, 1978
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 Waters Assoc., Inc.

  • K811975 — MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL (July 27, 1981)
  • K802481 — 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH (October 31, 1980)
  • K801852 — MRM-2 OXYGEN CONSUMPTION MONITOR (August 20, 1980)
  • K801431 — PAN-AM MYELOGRAM TRAY (August 12, 1980)
  • K791661 — SYSTEM CONTROLLER 720 SERIES (September 24, 1979)
  • K791026 — 4F STERILE BALLOON-LESS, CATHETER 913-28 (June 22, 1979)
  • K782175 — CARTRIDGE HOLDER, RCM 100 (February 15, 1979)
  • K790145 — SOLVENT DELIVERY SYSTEM (February 15, 1979)
  • K781805 — CARDIAC COMPUTERS, CO-10 & CO-10R (January 29, 1979)
  • K781915 — DATA MODULE (January 10, 1979)

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