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510(k) K946057

AQUALARM MOISTURE SENSOR MODEL P85000 by Pegasus Research Corp. — Product Code BYH

K946057 is an FDA 510(k) premarket notification submitted by Pegasus Research Corp. for the device "AQUALARM MOISTURE SENSOR MODEL P85000". The FDA issued a decision of Substantially Equivalent on May 5, 1995. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Pegasus Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1995
Date Received
December 12, 1994
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 Pegasus Research Corp.

  • K122857 — HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, (November 7, 2012)
  • K020700 — PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY (April 26, 2004)
  • K013856 — PMH 1000 HEATED HUMIDIFIER (February 21, 2003)
  • K983783 — HEATED HUMIDIFIER (October 24, 2000)
  • K962534 — THERA-MIST NEBULIZER MODEL-P3000 (February 28, 1997)
  • K915890 — AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED (June 24, 1992)
  • K914465 — AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 (March 31, 1992)
  • K903489 — THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 (December 10, 1990)
  • K893942 — THERA-MIST(TM) NEBULIZER, MODEL 30000 (August 28, 1989)
  • K894000 — THERA-MIST HUMIDIFIER (August 28, 1989)

Other clearances for product code BYH

  • K932722 — CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM (August 6, 1993)
  • K921624 — DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (June 30, 1992)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)
  • K897057 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 16, 1990)
  • K895479 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (March 9, 1990)
  • K900591 — VENT-TRAP CAT# WR1000 (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