Printer Interface (K970305)
510(k) K970305
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970305 | Date15 Aug 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Printer Interface
- 510(k) Number
- FDA Product Code
- DXH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Printer Interface (K970305) is a Transmitter and Receiver, Electrocardiograph, Telephone device, classified under product code DXH. It serves as an intermediary to transmit electrocardiogram (ECG) data from a Micromedical ECG monitor to a standard inkjet printer, enabling the generation of printed ECG recordings on letter-sized paper. This facilitates clinical documentation and review of cardiac activity in a healthcare setting.
The device is supplied as a reusable Class 2 medical device, intended for use in clinical environments where ECG data must be printed for patient records or diagnostic assessment. It connects to compatible Micromedical ECG monitors and interfaces with third-party printers (e.g., Canon or Hewlett Packard models) via standard connectivity protocols. No regulatory approval beyond the FDA 510(k) clearance (K970305) is stated, and its use is governed by the Traditional 510(k) pathway under the Cardiovascular advisory committee. Storage and handling follow standard medical device protocols for reusable equipment.
Other devices from Micro Medical, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Printer Interface (K970305) used for?
The Printer Interface (K970305) acts as a transmitter and receiver to bridge ECG data from Micromedical ECG monitors to standard inkjet printers. Its primary purpose is to generate printed ECG recordings on letter-sized paper, facilitating clinical documentation and diagnostic review of cardiac activity in healthcare settings.
How is the Printer Interface supplied and what type of device is it?
The Printer Interface is supplied as a reusable Class 2 medical device. It is designed for clinical environments where printed ECG records are required for patient documentation or diagnostic assessment, ensuring compatibility with Micromedical ECG monitors and third-party printers like Canon or HP models.
Is the Printer Interface single-use or reusable?
The Printer Interface is explicitly designed as a reusable device. This classification aligns with standard medical device protocols for reusable equipment, ensuring durability and repeated use in clinical settings where printed ECG records are essential.
Which printers are compatible with the Printer Interface?
The Printer Interface interfaces with third-party inkjet printers, including but not limited to models from Canon and Hewlett Packard. It connects via standard protocols to enable the printing of ECG data from compatible Micromedical ECG monitors.
How should the Printer Interface be stored and handled?
The Printer Interface follows standard medical device protocols for reusable equipment. This includes proper cleaning, disinfection, and storage in a clean, dry environment to maintain functionality and ensure compliance with healthcare facility guidelines for reusable medical devices.