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Validation Of The Breathid System, For The Detection Of Helicbactor Pylori
FDA 510(k)Class I (US FDA 510(k))
510(k) K011668
Identifiers
- 510(k) Number
- K011668 FDA 510(k)
- FDA Product Code
- MSQ FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3110 FDA 510(k)
- Regulation Number
- 866.3110 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Validation Of The Breathid System, For The Detection Of Helicbactor Pylori by Oridion Medical 1987 Ltd. — Class I — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011668 | Class I | Active |
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Manufacturer
- Manufacturer
- Oridion Medical 1987 Ltd.
- FDA Applicant
- Oridion Medical 1987 , Ltd.
Sources (1)
- FDA 510(k) K011668 24 fields · synced Jun 19, 2026