Atlas FDA

AQUAVALVE

FDA 510(k) clearance K864147 · decided 1986-12-05

Clearance details

K-number
K864147
Device name
AQUAVALVE
Applicant
Respiratory Care, Inc.
Decision
Substantially Equivalent
Date received
1986-10-22
Decision date
1986-12-05
Days to decision
44 days
Clearance type
Traditional
Product code
BYH
Device class
1
Regulation number
868.5995
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Arlington Heights, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AQUALARM MOISTURE SENSOR MODEL P85000 (K946057)Pegasus Research Corp.1995-05-05
CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM (K932722)Carie Med-Tech Services, Inc.1993-08-06
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (K921624)Intertech Resources, Inc.1992-06-30
THAYER SUCTION EVACUATION CONDENSATE COLLECTION (K900047)Thayer Medical Corp.1990-04-23
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (K897057)Thayer Medical Corp.1990-03-16
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (K895479)Thayer Medical Corp.1990-03-09
VENT-TRAP CAT# WR1000 (K900591)Ventlab Corp.1990-03-09
THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM (K885088)Thayer Medical Corp.1989-01-12
INTERTECH LARGE VOLUME WATER TRAP (LVW) (K882739)Intertech Resources, Inc.1988-08-09
SAFETY DRAIN (K881790)Ballard Medical Products1988-06-21
DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (K873447)Dhd Medical Products Div. Diemolding Corp.1987-10-30
SELF-SEALING WATER TRAP/ACCESSORIES (K860884)Dhd Medical Products Div. Diemolding Corp.1986-03-19

Recalls involving this device

No recalls on record reference this clearance.