TONOMITOR(TM)— 510(k) K870606
Substantially EquivalentTonometrics Holdings SA C/O Mackeen Consultants
FDA 510(k) clearance K870606 for TONOMITOR(TM), Substantially Equivalent on 1987-04-10. Applicant: Tonometrics Holdings SA C/O Mackeen Consultants.
Clearance details
- Applicant
- Tonometrics Holdings SA C/O Mackeen Consultants
- Product code
- Code FFT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethesda, MD, US
Adverse events under product code FFT
product code FFT- Injury
- 595
- Malfunction
- 2,175
- Other
- 1
- Total
- 2,771
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.