DeviceClearance

INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS— 510(k) K142036

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K142036 for INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS, Substantially Equivalent on 2014-08-25. Applicant: B.Braun Medical, Inc.. Device class: 2.

Clearance details

Applicant
B.Braun Medical, Inc.
Product code
Code FPA
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Allentown, PA, US
Download summary PDFView on FDA.gov ↗

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More clearances from B.Braun Medical, Inc.

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Adverse events under product code FPA

product code FPA
Death
95
Injury
14,421
Malfunction
125,815
Other
30
Total
140,361

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 K142036

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 K142036.

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