BESMED JET NEBULIZER BOTTLE SET

Nebulizer (direct Patient Interface)

BESMED HEALTH BUSINESS CORP.

The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Besmed Jet Nebulizer Bottle Set.

Pre-market Notification Details

• Device ID: K091272
• 510k Number: K091272
• Device Name: BESMED JET NEBULIZER BOTTLE SET
• Classification: Nebulizer (direct Patient Interface)
• Applicant: BESMED HEALTH BUSINESS CORP. 58 FU-CHIUN ST. Hsin Chu City, TW 300
• Contact: Ke-min Jen
• Correspondent: Ke-min Jen; BESMED HEALTH BUSINESS CORP. 58 FU-CHIUN ST. Hsin Chu City, TW 300
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-30
• Decision Date: 2009-11-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04716770313412	K091272	000
00840117300033	K091272	000
00888277682057	K091272	000
00888277682040	K091272	000
00888277682033	K091272	000
10080196715541	K091272	000
40080196715566	K091272	000
40080196715559	K091272	000
40080196715535	K091272	000
00840117300040	K091272	000
00616784560830	K091272	000
00616784560939	K091272	000
04716770312002	K091272	000
04716770311807	K091272	000
04716770311425	K091272	000
04716770311418	K091272	000
04716770311210	K091272	000
04716770311111	K091272	000
04716770311005	K091272	000
00616784561639	K091272	000
20888277699219	K091272	000
10888277692107	K091272	000
00840117308831	K091272	000
00840117308732	K091272	000
00840117308718	K091272	000
00840117308695	K091272	000
00682891365552	K091272	000
00848530087326	K091272	000
00848530060800	K091272	000
10848530060791	K091272	000
00840117319455	K091272	000
06970384250800	K091272	000
16970384250807	K091272	000
00850024759022	K091272	000
10888277420632	K091272	000
20888277699233	K091272	000
20888277699226	K091272	000
20888277699202	K091272	000
20888277657622	K091272	000
06970384250824	K091272	000
06970384250817	K091272	000
10848530060784	K091272	000
00616784560632	K091272	000
10822383115471	K091272	000
40872237005091	K091272	000
40872237004858	K091272	000
40872237004834	K091272	000
40872237004827	K091272	000
10853292007533	K091272	000
10853292007526	K091272	000
10853292007519	K091272	000
10822383116508	K091272	000
10822383116515	K091272	000
10822383527830	K091272	000
00616784560533	K091272	000
00616784560434	K091272	000
00616784560335	K091272	000
00616784560236	K091272	000
00616784560137	K091272	000
00813880023508	K091272	000
10822383538393	K091272	000
10822383537983	K091272	000
10853292007502	K091272	000
10853292007496	K091272	000
04716770316000	K091272	000
04716770315812	K091272	000
04716770315423	K091272	000
04716770315416	K091272	000
04716770315232	K091272	000
04716770315133	K091272	000
04716770315119	K091272	000
04716770315003	K091272	000
04716770316116	K091272	000
04716770316215	K091272	000
04716770316420	K091272	000
10853292007489	K091272	000
10853292007472	K091272	000
04716770324104	K091272	000
04716770324005	K091272	000
04716770317809	K091272	000
04716770317403	K091272	000
04716770317229	K091272	000
04716770317120	K091272	000
04716770313610	K091272	000