Multitrak-Plus
by Zymed Medical Instrumentation
510(k) K930894
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930894 | Date1 Nov 1993 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DSH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
Recorder, Magnetic Tape, Medical is a device used for recording physiological signals onto magnetic tape. It is classified under the Cardiovascular medical specialty.
The device was cleared via the FDA 510(k) pathway under K930894, with product code DSH and regulation number 870.2800. It is a Class II device intended for use in cardiovascular applications.
Other devices from Zymed Medical Instrumentation
Questions
AI-generated answers, 19 Sep 2026
What is the MULTITRAK-PLUS device used for?
The MULTITRAK-PLUS is a medical device used for recording physiological signals onto magnetic tape, specifically classified under the Cardiovascular medical specialty.
How is the MULTITRAK-PLUS supplied and is it single-use or reusable?
The device is supplied as a recorder for magnetic tape, but the data does not specify whether it is single-use or reusable.
What are the storage requirements for the MULTITRAK-PLUS?
The device data does not provide specific storage requirements for the MULTITRAK-PLUS.
What regulatory pathway was used for the MULTITRAK-PLUS?
The MULTITRAK-PLUS was cleared via the FDA 510(k) pathway under K930894, with product code DSH and regulation number 870.2800.