SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM— 510(k) K852608
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K852608 for SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM, Substantially Equivalent on 1985-09-27. Applicant: Ge Medical Systems Information Technologies.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code HGM
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wallingford, CT, 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.