GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)— 510(k) K945689
Substantially EquivalentCalmed Technology, Inc.
FDA 510(k) clearance K945689 for GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM), Substantially Equivalent on 1995-02-08. Applicant: Calmed Technology, Inc..
Clearance details
- Applicant
- Calmed Technology, Inc.
- Product code
- Code EWO
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union City, CA, US
Adverse events under product code EWO
product code EWO- Other
- 2
- Total
- 2
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.