HEWLETT PACKARD MODEL M1353A FETAL MONITOR— 510(k) K921956
Substantially EquivalentHewlett-Packard Co.
FDA 510(k) clearance K921956 for HEWLETT PACKARD MODEL M1353A FETAL MONITOR, Substantially Equivalent on 1993-09-24. Applicant: Hewlett-Packard Co.. Device class: 2.
Clearance details
- Applicant
- Hewlett-Packard Co.
- Product code
- Code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Germany, DE
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Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
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.