ALPHA TALKER— 510(k) K935317
Substantially Equivalent for Some IndicationsPrentke Romich Co.
FDA 510(k) clearance K935317 for ALPHA TALKER, Substantially Equivalent for Some Indications on 1994-03-28. Applicant: Prentke Romich Co..
Clearance details
- Applicant
- Prentke Romich Co.
- Product code
- Code ITI
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Wooster, OH, US
Adverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
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.