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510(k) K954194

DISPOSABLE HME/FILTER by Engstrom Medical — Product Code BYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1995
Date Received
September 6, 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 Engstrom Medical

  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)

Other clearances for product code BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)
  • K952750 — HUMID-VENT 1 (July 20, 1995)