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510(k) K921624

DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS by Intertech Resources, Inc. — Product Code BYH

K921624 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS". The FDA issued a decision of Substantially Equivalent on June 30, 1992. 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
June 30, 1992
Date Received
April 6, 1992
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 (December 17, 1996)
  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (June 8, 1995)
  • K952062 — PFT FILTER (June 8, 1995)
  • K935036 — HEPA FILTERED HEAT AND MOISTURE EXCHANGER (January 25, 1994)
  • K930816 — HEPA FILTERED HME (July 1, 1993)
  • K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (October 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 (August 6, 1993)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)
  • K897057 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 16, 1990)
  • K900591 — VENT-TRAP CAT# WR1000 (March 9, 1990)
  • K895479 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (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