PM3300 Intermittent Vacuum Regulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K944479 FDA 510(k)
- FDA Product Code
- KDP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6740 FDA 510(k)
- Regulation Number
- 880.6740 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PM3300 Intermittent Vacuum Regulator is a Class II medical device designed as a vacuum regulator for clinical use. It provides controlled suction pressure cycling, enabling intermittent vacuum applications in patient care settings. The device is intended for use in general hospital environments, where precise suction regulation is required for procedures such as suctioning or drainage.
This device operates in an intermittent mode, cycling between an 8-second off phase and a 16-second on phase to deliver preset vacuum levels. Supplied as a reusable medical instrument, it is regulated under FDA 510(k) clearance (K944479) and adheres to the regulatory requirements outlined in 21 CFR 880.6740. The PM3300 includes a peak vacuum limit feature to prevent over-adjustment of suction pressure, ensuring safe and consistent operation in clinical settings.
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: 3300 Series Preset Continuous-Intermittent 3-Mode, PRECISION MEDICAL PM3300 USER MANUAL Pdf Download, PDF USER MANUAL - Precision Medical, Inc., Precision medical PM3300 Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K944479 | Class II | Active |
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Manufacturer
- Manufacturer
- Precision Medical, Inc.
Sources (1)
- FDA 510(k) K944479 24 fields · synced Oct 1, 2026