PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600— 510(k) K925638

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K925638 for PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600, Substantially Equivalent on 1993-10-18. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant
Baxter Healthcare Corp
Product code
Code DXO
Device class
Class 2
Regulation
21 CFR 870.2870
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Ana, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DXO

view all

More clearances from Baxter Healthcare Corp

view all

Adverse events under product code DXO

product code DXO
Death
10
Injury
156
Malfunction
884
Total
1,050

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 K925638

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 K925638.

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