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510(k) K882739

INTERTECH LARGE VOLUME WATER TRAP (LVW) by Intertech Resources, Inc. — Product Code BYH

K882739 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "INTERTECH LARGE VOLUME WATER TRAP (LVW)". The FDA issued a decision of Substantially Equivalent on Aug 9, 1988. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Intertech Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 9, 1988
Date Received
Jul 1, 1988
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 by Intertech Resources, Inc.

  • K961318 — 1ST RESPONSE DISPOSABLE MANOMETER (Dec 17, 1996)
  • K955008 — HEAT & MOISTURE EXCHANGER (Jan 30, 1996)
  • K953580 — HEAT MOISTURE EXCHANGER (Sep 15, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (Aug 11, 1995)
  • K952062 — PFT FILTER (Jun 8, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (Jun 8, 1995)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (Jun 8, 1995)
  • K935036 — HEPA FILTERED HEAT AND MOISTURE EXCHANGER (Jan 25, 1994)
  • K930816 — HEPA FILTERED HME (Jul 1, 1993)
  • K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (Oct 30, 1992)

Other clearances for product code BYH

  • K946057 — AQUALARM MOISTURE SENSOR MODEL P85000 (May 5, 1995)
  • K932722 — CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM (Aug 6, 1993)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (Jun 30, 1992)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (Apr 23, 1990)
  • K897057 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (Mar 16, 1990)
  • K895479 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (Mar 9, 1990)
  • K900591 — VENT-TRAP CAT# WR1000 (Mar 9, 1990)
  • K885088 — THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM (Jan 12, 1989)
  • K881790 — SAFETY DRAIN (Jun 21, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (Oct 30, 1987)

FDA data resources