PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600— 510(k) K925638
Substantially EquivalentBaxter 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
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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 recordMatched 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.