Medical Device Manufacturer · AU , Australia

Ashai Co. , Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1985
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ashai Co. , Ltd. Anesthesiology ✕
10 devices
1-10 of 10
Cleared May 15, 1987
AEROSOL ONE, NEBULIZER PUMP
K870428 · BTI
Anesthesiology · 101d
Cleared Apr 24, 1986
AEROSOL ONE
K852622 · BTI
Anesthesiology · 308d
Cleared Sep 26, 1985
MAXI-NEB
K852627 · CCQ
Anesthesiology · 98d
Cleared Sep 18, 1985
OXY-DIAL
K852618 · BYF
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-ONE
K852623 · BYG
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-TWO
K852624 · BYG
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-TUBE
K852625 · CAT
Anesthesiology · 90d
Cleared Sep 18, 1985
AERO-MASK ONE
K852626 · BYG
Anesthesiology · 90d
Cleared Sep 18, 1985
NASAL ONE
K852628 · CAT
Anesthesiology · 90d
Cleared Sep 18, 1985
AERO-MASK TWO
K852629 · BYG
Anesthesiology · 90d
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All12 Anesthesiology 10 Gastroenterology & Urology 1 Obstetrics & Gynecology 1