Teca/Medelec 'concept' P420
by Teca, Inc.
510(k) K884870
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884870 | Date23 Feb 1989 | 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- Withdrawn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
- GWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1870
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Teca Medelec Concept P420 is an electrical evoked response stimulator. It is designed for use in neurology applications to deliver electrical stimuli for diagnostic testing.
This device is authorized under FDA 510(k) number K884870. It is manufactured by Teca, Inc. and is categorized under regulation number 882.1870.
Other devices from Teca, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary use of the Teca Medelec Concept P420?
The device is an electrical evoked response stimulator designed specifically for neurology applications. It is used to deliver electrical stimuli to a patient to facilitate diagnostic testing.
Is the Teca Medelec Concept P420 authorized for use?
Yes, this device is authorized under FDA 510(k) number K884870. It is categorized under regulation number 882.1870 as an evoked response electrical stimulator.
Who is the manufacturer of this stimulator?
The Teca Medelec Concept P420 is manufactured by Teca, Inc., located in Pleasantville, New York.