TOITU FETAL ACTOCARDIOGRAPH, MT-332— 510(k) K894036
Substantially EquivalentToitu of America, Inc.
FDA 510(k) clearance K894036 for TOITU FETAL ACTOCARDIOGRAPH, MT-332, Substantially Equivalent on 1989-11-06. Applicant: Toitu of America, Inc..
Clearance details
- Applicant
- Toitu of America, Inc.
- Product code
- Code HGM
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, PA, US
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.