Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line
FDA 510(k) K013845 · Oridion Medical 1987 , Ltd.
510(k) numberK013845
Submission
- Device name
- Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line
- Applicant
- Oridion Medical 1987 , Ltd.
Jerusalem, IL - Received
- November 20, 2001
- Decision date
- November 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line cleared by the FDA?
Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line (K013845) received a 510(k) decision of Substantially Equivalent on November 29, 2001, 9 days after the submission was received.
What is the product code of K013845?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.