SAECG CARDIOGRAPH MODEL M1754A— 510(k) K913997
Substantially EquivalentHewlett-Packard Co.
FDA 510(k) clearance K913997 for SAECG CARDIOGRAPH MODEL M1754A, Substantially Equivalent on 1992-03-06. Applicant: Hewlett-Packard Co.. Device class: 2.
Clearance details
- Applicant
- Hewlett-Packard Co.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcminnville, OR, US
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Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.