Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
FDA 510(k) clearance K181467 · decided 2019-02-08
Clearance details
- K-number
- K181467
- Device name
- Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
- Applicant
- Oridion Medical 1987 , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-04
- Decision date
- 2019-02-08
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jerusalem, IL
- Third-party review
- No
- Expedited review
- No
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