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Company · AU

Ashai Co. , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1987. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
BYG	Mask, Oxygen	4
BTI	Compressor, Air, Portable	2
CAT	Cannula, Nasal, Oxygen	2
BYF	Mask, Oxygen, Low Concentration, Venturi	1
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	1
HIS	Condom	1
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
May 15, 1987	K870428	AEROSOL ONE, NEBULIZER PUMP Ashai Co. , Ltd., AU	BTI
Apr 24, 1986	K852622	AEROSOL ONE Ashai Co. , Ltd., AU	BTI
Oct 31, 1985	K852620	SAFE.N.SURE Ashai Co. , Ltd., AU	HIS
Sep 26, 1985	K852627	MAXI-NEB Ashai Co. , Ltd., AU	CCQ
Sep 18, 1985	K852629	AERO-MASK TWO Ashai Co. , Ltd., AU	BYG
Sep 18, 1985	K852628	NASAL ONE Ashai Co. , Ltd., AU	CAT
Sep 18, 1985	K852626	AERO-MASK ONE Ashai Co. , Ltd., AU	BYG
Sep 18, 1985	K852625	OXY-TUBE Ashai Co. , Ltd., AU	CAT
Sep 18, 1985	K852624	OXY-TWO Ashai Co. , Ltd., AU	BYG
Sep 18, 1985	K852623	OXY-ONE Ashai Co. , Ltd., AU	BYG
Sep 18, 1985	K852618	OXY-DIAL Ashai Co. , Ltd., AU	BYF
Aug 27, 1985	K852619	URI-SURE Ashai Co. , Ltd., AU	KNX

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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