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510(k) K770857

DIALYSIS MACHINE, CENTRY II by Cobe Laboratories, Inc. — Product Code FJF

K770857 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "DIALYSIS MACHINE, CENTRY II". The FDA issued a decision of Substantially Equivalent on October 4, 1977. The device falls under product code FJF (Detector, Air Bubble), a Class II device regulated under 21 CFR 876.5820. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1977
Date Received
May 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Air Bubble
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cobe Laboratories, Inc.

  • K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (May 11, 1993)
  • K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (March 22, 1991)
  • K905793 — COBE CENTRY 2 BICART OPTION KIT (February 12, 1991)
  • K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT (February 11, 1991)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (December 17, 1990)
  • K904566 — NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (December 12, 1990)
  • K902758 — COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (August 23, 1990)
  • K902759 — COBE CLOSED WOUND DRAINAGE KIT (July 18, 1990)

Other clearances for product code FJF

  • K904992 — MINNILERT AIR DETECTOR (February 5, 1991)
  • K891327 — NICKLE-TITANIUM ORTHODONTIC WIRE (May 10, 1989)
  • K781330 — BLOOD LEVEL DETECTOR-MODEL 7601 (August 31, 1978)
  • K780582 — DETECTOR, BUBBLE & FOAM (June 22, 1978)

FDA data resources