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510(k) K953580

HEAT MOISTURE EXCHANGER by Intertech Resources, Inc. — Product Code BYD

K953580 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "HEAT MOISTURE EXCHANGER". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Intertech Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
August 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Heat And Moisture (Artificial Nose)
Device Class
Class I
Regulation Number
868.5375
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)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (June 8, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (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)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (June 30, 1992)

Other clearances for product code BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K954194 — DISPOSABLE HME/FILTER (October 20, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)
  • K952844 — HUMID-VENT 2 (July 20, 1995)

FDA data resources