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510(k) K946057

Device
AQUALARM MOISTURE SENSOR MODEL P85000
Applicant
PEGASUS RESEARCH CORP.
510(k) number
K946057
Product code
BYH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-05
Date received
1994-12-12
Regulation
868.5995
Classification name
Drain, Tee (water Trap)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KENNETH G MILLER
Address
775 W. 17th St. Suite D Costa Mesa CA US 92627 92627

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BYH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932722CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEMCarie Med-Tech Services, Inc.1993-08-06
K921624DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITSIntertech Resources, Inc.1992-06-30
K900047THAYER SUCTION EVACUATION CONDENSATE COLLECTIONThayer Medical Corp.1990-04-23
K897057THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEMThayer Medical Corp.1990-03-16
K900591VENT-TRAP CAT# WR1000Ventlab Corp.1990-03-09
K895479THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEMThayer Medical Corp.1990-03-09
K885088THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEMThayer Medical Corp.1989-01-12
K882739INTERTECH LARGE VOLUME WATER TRAP (LVW)Intertech Resources, Inc.1988-08-09
K881790SAFETY DRAINBallard Medical Products1988-06-21
K873447DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATORDhd Medical Products Div. Diemolding Corp.1987-10-30
K864147AQUAVALVERespiratory Care, Inc.1986-12-05
K860884SELF-SEALING WATER TRAP/ACCESSORIESDhd Medical Products Div. Diemolding Corp.1986-03-19
K860883SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITSDhd Medical Products Div. Diemolding Corp.1986-03-19
K853665SPLASH ADAPTOROhio Medical Research, Inc.1985-10-10
K834573AQUA TRAPAirlife, Inc.1984-03-05

Legacy Summary#

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FDA Review#

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