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510(k) K952750

HUMID-VENT 1 by Gibeck, Inc. — Product Code BYD

K952750 is an FDA 510(k) premarket notification submitted by Gibeck, Inc. for the device "HUMID-VENT 1". The FDA issued a decision of Substantially Equivalent on July 20, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Gibeck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1995
Date Received
June 15, 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 Gibeck, Inc.

  • K965016 — ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) (December 2, 1997)
  • K964377 — THERMAL REGULATION SYSTEM BLANKET (April 23, 1997)
  • K964382 — HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(1940 (April 15, 1997)
  • K960511 — GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET (January 13, 1997)
  • K954828 — ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT (May 2, 1996)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)
  • K952844 — HUMID-VENT 2 (July 20, 1995)
  • K952084 — HUMID-VENT FILTER PEDI (June 12, 1995)

Other clearances for product code BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K954194 — DISPOSABLE HME/FILTER (October 20, 1995)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)

FDA data resources