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510(k) K870538

MODEL 192 PRINTER by Advanced Medical Products, Inc. — Product Code DSF

K870538 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "MODEL 192 PRINTER". The FDA issued a decision of Substantially Equivalent on April 23, 1987. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1987
Date Received
February 9, 1987
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 Advanced Medical Products, Inc.

  • K110979 — DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE, (October 20, 2011)
  • K000932 — ARACHNOPHLEBECTOMY NEEDLE (May 17, 2000)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K921426 — ULTRA PCI (October 5, 1992)
  • K912925 — ULTRA PVD (June 18, 1992)
  • K915658 — SPECTRA ECG (June 10, 1992)
  • K896102 — MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR (January 18, 1990)
  • K896103 — MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR (January 18, 1990)
  • K881905 — MODEL MICRO SI AMBULATORY ECG MONITOR (August 2, 1988)
  • K872508 — MODEL MICRO FD+ AMBULATORY ECG MONITOR (September 25, 1987)

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