FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
510(k) Clearances
/ K945374
510(k) K945374
ACU-HALT by
Eva-Health USA, Inc.
— Product Code
LDQ
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1995
Date Received
November 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances for product code LDQ
K993797
— EC-7701 FLUID WARMING CABINET (January 20, 2000)
K992258
— HOT SHOT FLUID WARMER IV FLUIDS (January 12, 2000)
K981032
— PIV SYSTEM (September 2, 1998)
K973747
— CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
K955661
— ACU-HALT (December 30, 1996)
K955776
— ACU-LAB (June 5, 1996)
K944961
— PERSONAL ALARM SYSTEM (PAS) (August 7, 1995)
K942810
— PALCO LABS COLD POUCH (June 28, 1995)
K930884
— MEDICAL PROCEDURE TRAY, MODIFICATION (March 21, 1995)
K934703
— MEDICOOL PROTECTALL (January 26, 1994)