Identifiers
- 510(k) Number
- K850791 FDA 510(k)
- FDA Product Code
- DRO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5550 FDA 510(k)
- Regulation Number
- 870.5550 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MDI 2000 - Pulse Generator is a pacemaker, cardiac, external transcutaneous (non-invasive) device. It is designed to generate electrical pulses for cardiac pacing purposes.
This device is supplied by Micromedical Devices, Inc. and is authorized under FDA 510K clearance with product code DRO. It is a Class II device regulated under 870.5550, with a decision date of 1985-06-19.
Frequently asked questions
What is the MDI 2000 Pulse Generator used for?
The MDI 2000 Pulse Generator is a cardiac pacemaker designed to generate electrical pulses for cardiac pacing purposes. It is an external transcutaneous (non-invasive) device that provides temporary cardiac pacing support when needed.
How is the MDI 2000 Pulse Generator supplied?
The MDI 2000 Pulse Generator is supplied by Micromedical Devices, Inc. It is a Class II device regulated under 870.5550, with FDA 510K clearance and product code DRO. The device is manufactured at 12741 E. Caley Ave., Suite 128, Englewood, CO 80111.
What is the regulatory status of the MDI 2000 Pulse Generator?
The MDI 2000 Pulse Generator is authorized under FDA 510K clearance with a decision date of 1985-06-19. It was determined to be substantially equivalent to other devices in its class and reviewed by the Cardiovascular advisory committee.
Is the MDI 2000 Pulse Generator reusable or single-use?
The device data does not specify whether the MDI 2000 Pulse Generator is designed for single-use or reuse. For specific usage instructions and disposal guidelines, users should consult the manufacturer's documentation or contact Micromedical Devices, Inc. directly.
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: MDI 2000 - PULSE GENERATOR 510 (k) K850791 - FDA.report, Micromedical Devices… — 7 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K850791 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micromedical Devices, Inc.
Sources (1)
- FDA 510(k) K850791 24 fields · synced Sep 24, 2026