DeviceClearance

PULMOSAL— 510(k) K130091

Substantially Equivalent

Pharmacaribe

FDA 510(k) clearance K130091 for PULMOSAL, Substantially Equivalent on 2013-03-13. Applicant: Pharmacaribe. Device class: 2.

Clearance details

Applicant
Pharmacaribe
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
Special
Location
Bonita Springs, FL, US
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 K130091

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 K130091.

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