MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE— 510(k) K013845
Substantially EquivalentOridion Medical 1987 , Ltd.
FDA 510(k) clearance K013845 for MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE, Substantially Equivalent on 2001-11-29. Applicant: Oridion Medical 1987 , Ltd.. Device class: 2.
Clearance details
- Applicant
- Oridion Medical 1987 , Ltd.
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Jerusalem, IL
Recent devices under product code CCK
view allMore clearances from Oridion Medical 1987 , Ltd.
view all- K200594 — Capnostream 35 Portable Respiratory Monitor
- K181624 — Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
- K181467 — Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
- K150272 — Capnostream 35 Portable Respiratory Monitor
- K123690 — CAPNOSTREAM20P WITH HIFI C02 MONITORING
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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.