6400ST Interface MODULE-RS232
by Bird Products Corp. 510(k)
Active
510(k) K880721
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880721 | Date14 Apr 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The 6400ST Interface Module-RS232 is a Class 2 medical device that serves as an interface module with RS232 connectivity. It is designed for facility use and is classified under product code CBK.
This device is manufactured by Bird Products Corp. and was cleared via the FDA 510(k) pathway on April 14, 1988. It is intended for use in anesthesiology settings and is supplied as a single unit without specific information regarding sterility, single-use status, or MRI safety.
Other devices from Bird Products Corp.
Questions
AI-generated answers, 28 Sep 2026
What is the 6400ST Interface Module-RS232 used for?
The 6400ST Interface Module-RS232 is a Class 2 medical device designed for facility use in anesthesiology settings. It serves as an interface module with RS232 connectivity to facilitate communication between medical devices.
Is the 6400ST Interface Module-RS232 sterile or single-use?
The device is supplied as a single unit without specific information regarding sterility or single-use status. It is designed for facility use, suggesting it may be reusable within a healthcare setting.
What regulatory approvals does the 6400ST Interface Module-RS232 have?
The 6400ST Interface Module-RS232 was cleared via the FDA 510(k) pathway on April 14, 1988, with K number K880721. It is classified as substantially equivalent under product code CBK for anesthesiology devices.
Who manufactures the 6400ST Interface Module-RS232?
The device is manufactured by Bird Products Corp., located at 1100 Bird Center Dr., Palm Spring, CA 92262. The company has been involved in the production of various medical devices including ventilators and anesthesiology equipment.