Strive Dual Zone Peak Flow Meter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123945 FDA 510(k)
- FDA Product Code
- BZH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1860 FDA 510(k)
- Regulation Number
- 868.1860 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Strive Dual Zone Peak Flow Meter is a device for measuring peak expiratory flow in patients from five years old through adult. It provides accurate measurements for patient populations and accommodates flow rates from 50 to 800 L/min. The device is designed for individual or multi-patient use and features a dual zone display for patient education.
The meter is easy to clean for high-level disinfection and supports optional disposable mouthpieces for multi-patient use. It is supplied as a single device and is intended for use in clinical settings where peak flow monitoring is required. The device is classified under product code BZH and is regulated under regulation number 868.1860.
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: PDF monaghan means it matters - Tri-anim, PDF The Monaghan Advantage - Monaghan Medical, Strive® Dual Zone Peak Flow Meter Discontinued - Save Rite Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123945 | Class II | Active |
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Manufacturer
- Manufacturer
- Monaghan Medical Corp.
Sources (1)
- FDA 510(k) K123945 24 fields · synced Sep 21, 2026