DeviceClearance

INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION— 510(k) K141756

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K141756 for INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION, Substantially Equivalent on 2014-12-12. Applicant: Draeger Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant
Draeger Medical Systems, Inc.
Product code
Code MSX
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Andover, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MSX

product code MSX
Death
59
Total
59

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 K141756

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 K141756.

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