SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY— 510(k) K950888
Substantially EquivalentCalmed Technology, Inc.
FDA 510(k) clearance K950888 for SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY, Substantially Equivalent on 1995-03-21. 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.