VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI— 510(k) K011668
Substantially EquivalentOridion Medical 1987 , Ltd.
FDA 510(k) clearance K011668 for VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI, Substantially Equivalent on 2001-07-09. Applicant: Oridion Medical 1987 , Ltd.. Device class: 1.
Clearance details
- Applicant
- Oridion Medical 1987 , Ltd.
- Product code
- Code MSQ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3110
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jerusalem, IL
Recent devices under product code MSQ
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- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.