DeviceClearance

BESMED JET NEBULIZER BOTTLE SET— 510(k) K091272

Substantially Equivalent

Besmed Health Business Corp

FDA 510(k) clearance K091272 for BESMED JET NEBULIZER BOTTLE SET, Substantially Equivalent on 2009-11-10. Applicant: Besmed Health Business Corp. Device class: 2.

Clearance details

Applicant
Besmed Health Business Corp
Product code
Code CAF
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hsin Chu City, TW
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAF

product code CAF
Death
22
Injury
125
Malfunction
613
Other
11
Total
771

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K091272

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091272.

Data sourced from openFDA. This site is unofficial and independent of the FDA.