AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)— 510(k) K003330
Substantially EquivalentAktina Medical Physics Corp.
FDA 510(k) clearance K003330 for AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC), Substantially Equivalent on 2001-01-04. Applicant: Aktina Medical Physics Corp.. Device class: 2.
Clearance details
- Applicant
- Aktina Medical Physics Corp.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Congers, NY, US
Recent devices under product code IYE
view allMore clearances from Aktina Medical Physics Corp.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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.