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510(k) K781918

IRRIGATOR, BODY CAVITY by Bci, Inc. — Product Code EYN

K781918 is an FDA 510(k) premarket notification submitted by Bci, Inc. for the device "IRRIGATOR, BODY CAVITY". The FDA issued a decision of Substantially Equivalent on February 15, 1979. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. Bci, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1979
Date Received
November 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Irrigation, Sterile
Device Class
Class II
Regulation Number
876.5980
Review Panel
SU
Submission Type

Other clearances by Bci, Inc.

  • K030407 — ADVISOR, MODEL 9200 (August 19, 2003)
  • K031742 — BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER (August 18, 2003)
  • K020739 — BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR (June 3, 2002)
  • K020350 — BCI 3180 PULSE OXIMETER (April 30, 2002)
  • K013862 — BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM (February 21, 2002)
  • K013171 — 3420 DIGIT PULSE OXIMETER, MODEL 3420 (January 3, 2002)
  • K011156 — BCI 3403 SLEEP SCREENING PULSE OXIMETER (June 14, 2001)
  • K010770 — BCI ADVISOR VITAL SIGNS MONITOR (9200) (June 12, 2001)
  • K011177 — BCI ADVISOR VITAL SIGNS MONITOR (9200) (May 23, 2001)
  • K001770 — BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A (July 5, 2000)

Other clearances for product code EYN

  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K900148 — KIT PAK IRRIGATION TRAY (April 23, 1990)
  • K900737 — PISTON IRRIGATION TRAY (April 19, 1990)
  • K900736 — BULB IRRIGATION TRAY (April 17, 1990)
  • K801783 — CATHETER IRRIGATION TRAYS, #3300, 3310 & (August 13, 1980)
  • K792082 — GAVAGE FEEDING SET (November 13, 1979)

FDA data resources