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510(k) K932722

CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM by Carie Med-Tech Services, Inc. — Product Code BYH

K932722 is an FDA 510(k) premarket notification submitted by Carie Med-Tech Services, Inc. for the device "CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
June 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drain, Tee (Water Trap)
Device Class
Class I
Regulation Number
868.5995
Review Panel
AN
Submission Type

Other clearances for product code BYH

  • K946057 — AQUALARM MOISTURE SENSOR MODEL P85000 (May 5, 1995)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (June 30, 1992)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)
  • K897057 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 16, 1990)
  • K895479 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 9, 1990)
  • K900591 — VENT-TRAP CAT# WR1000 (March 9, 1990)
  • K885088 — THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM (January 12, 1989)
  • K882739 — INTERTECH LARGE VOLUME WATER TRAP (LVW) (August 9, 1988)
  • K881790 — SAFETY DRAIN (June 21, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (October 30, 1987)

FDA data resources