Boehringer MRI Suction Regulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013976 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 Boehringer MRI Suction Regulator is a vacuum regulator device designed for use in medical settings. It is intended to be wall-mounted to a facility suction system and is part of the 3700 series of suction regulators.
This device is supplied by Boehringer Laboratories, LLC and is MRI-compatible. It is authorized under FDA 510(k) clearance with product code KDP and device class 2. The device is available in various models including 3708, 3718, and 3748.
Frequently asked questions
What is the Boehringer MRI Suction Regulator used for?
The Boehringer MRI Suction Regulator is a vacuum regulator device designed for medical settings. It is intended to be wall-mounted to a facility suction system as part of the 3700 series of suction regulators.
What models are available for the Boehringer MRI Suction Regulator?
The device is available in various models including 3708, 3718, and 3748. Each model offers the same core functionality as part of the 3700 series of suction regulators.
Is the Boehringer MRI Suction Regulator MRI-compatible?
Yes, the Boehringer MRI Suction Regulator is specifically designed to be MRI-compatible, making it suitable for use in MRI suites and other medical environments with magnetic resonance imaging equipment.
What is the regulatory status of the Boehringer MRI Suction Regulator?
The device is authorized under FDA 510(k) clearance with product code KDP and device class 2. It received clearance on January 8, 2002, with the decision code SESE indicating it was found substantially equivalent to predicate devices.
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 Mri Suction Regulator, PDF MRI Suction Regulator, Model 3708 - Suction Regulators - Boehringer Labs, BOEHRINGER 3708 USER MANUAL Pdf Download | ManualsLib, BOEHRINGER MRI SUCTION REGULATORY (K013976) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013976 | Class II | Active |
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Manufacturer
- Manufacturer
- Boehringer Laboratories, Llc
- FDA Applicant
- Boehringer Laboratories
Sources (1)
- FDA 510(k) K013976 24 fields · synced Sep 28, 2026