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510(k) K780582

DETECTOR, BUBBLE & FOAM by Hospal Medical Corp. — Product Code FJF

K780582 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "DETECTOR, BUBBLE & FOAM". The FDA issued a decision of Substantially Equivalent on June 22, 1978. The device falls under product code FJF (Detector, Air Bubble), a Class II device regulated under 21 CFR 876.5820. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1978
Date Received
April 12, 1978
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 Hospal Medical Corp.

  • K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER (July 24, 1989)
  • K884365 — MULTIFLOW(TM) 60 KIT (December 8, 1988)
  • K884326 — FILTRAL TM 8 HEMODIALYZER (December 5, 1988)
  • K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (October 12, 1988)
  • K872767 — FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER (December 29, 1987)
  • K871218 — MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (April 30, 1987)
  • K863961 — HOSPAL BIOSPAL 1800S (December 17, 1986)
  • K863592 — DISSCAP 80E, 110E, 140E, 160E (September 25, 1986)
  • K861156 — HOSPAL DIALYSATE FOR CAVHD (September 23, 1986)
  • K861230 — MONITRAL S (April 25, 1986)

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)
  • K770857 — DIALYSIS MACHINE, CENTRY II (October 4, 1977)

FDA data resources