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510(k) K901385

GABRIEL MEDICAL CLS THERMAL RECORDER by Gabriel Medical, Inc. — Product Code DSF

K901385 is an FDA 510(k) premarket notification submitted by Gabriel Medical, Inc. for the device "GABRIEL MEDICAL CLS THERMAL RECORDER". The FDA issued a decision of Substantially Equivalent on May 9, 1990. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Gabriel Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1990
Date Received
March 26, 1990
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 Gabriel Medical, Inc.

  • K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (June 27, 1996)
  • K945088 — GABRIEL URETERAL ILLUMINATOR SYSTEM II (February 7, 1995)
  • K945297 — INFRA VISION IMAGING SYSTEM (December 20, 1994)
  • K940019 — GABRIEL URETERAL ILLUMINATOR SYSTEM (May 2, 1994)

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)
  • 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)
  • K893561 — EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (August 25, 1989)

FDA data resources