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
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