Amastim 2000
by Amatech International, Inc. 510(k)
Active
510(k) K872704
Overview
The Amastim 2000 is a medical device classified under product code GZJ and has received FDA 510(k) clearance as substantially equivalent to a predicate device. It was reviewed by the Neurology advisory committee and cleared through the traditional 510(k) pathway.
The device was manufactured by Amatech International, Inc. in Houston, Texas, and received FDA clearance on January 22, 1988. It is identified by K number K872704 and was submitted for review on July 7, 1987.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872704 | Date22 Jan 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- GZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Amatech International, Inc.
Questions
What is the Amastim 2000 used for?
The Amastim 2000 is classified under product code GZJ and was reviewed by the Neurology advisory committee, indicating its intended use falls within neurology applications as determined by the FDA submission review process.
How was the Amastim 2000 cleared for market?
The Amastim 2000 received FDA 510(k) clearance through the traditional pathway, determined to be substantially equivalent to a predicate device, with clearance granted on January 22, 1988, under K number K872704.
Who manufactures the Amastim 2000 and where is it made?
The Amastim 2000 is manufactured by Amatech International, Inc. at their facility located at 2400 Central Pkwy., Suite K, Houston, Texas, 77092, United States.