DeviceClearance

PAGEWRITER TC 20, 30, 50, 70— 510(k) K113144

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K113144 for PAGEWRITER TC 20, 30, 50, 70, Substantially Equivalent on 2012-04-03. Applicant: Philips Medical Systems. Device class: 2.

Clearance details

Applicant
Philips Medical Systems
Product code
Code DPS
Device class
Class 2
Regulation
21 CFR 870.2340
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 DPS

product code DPS
Death
7
Total
7

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 K113144

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 K113144.

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