Altera Filter and HME/Filter— 510(k) K192713
Substantially EquivalentMeditera Tibbi Malzeme San VE Tic AS
FDA 510(k) clearance K192713 for Altera Filter and HME/Filter, Substantially Equivalent on 2020-03-16. Applicant: Meditera Tibbi Malzeme San VE Tic AS. Device class: 2.
Clearance details
- Applicant
- Meditera Tibbi Malzeme San VE Tic AS
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Izmir, TR
Recent devices under product code CAH
view allMore clearances from Meditera Tibbi Malzeme San VE Tic AS
view allAdverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
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 →
Recalls naming K192713
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192713.
Data sourced from openFDA. This site is unofficial and independent of the FDA.