Ventlab Pressurechek Disosable Column Manometer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120118 FDA 510(k)
- FDA Product Code
- CAP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2600 FDA 510(k)
- Regulation Number
- 868.2600 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ventlab Pressurechek Disposable Column Manometer is a device that provides visual indication of a patient's airway pressure during ventilation. It can be connected to manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits.
This device is a single patient use, non-sterile device. It is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) and is regulated under 868.2600. The device received FDA 510(k) clearance with K number K120118 in 2012, with a decision of Substantially Equivalent.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (K120118) — FDA 510(k ..., Ventlab Pressurechek Disosable Column Manometer - Beudamed, VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER 510 (k) K120118 - FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120118 | Class II | Active |
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Manufacturer
- Manufacturer
- Ventlab Corp.
Sources (1)
- FDA 510(k) K120118 24 fields · synced Sep 26, 2026