Sea Med Model 880
by Seamed Corp. 510(k)
Active
510(k) K823048
Overview
The Sea Med Model 880 is an external pulse-generator pacemaker classified as a Class 2 cardiovascular device under product code DTE. It is designed to generate electrical pulses for cardiac pacing in external applications.
The device received FDA 510(k) clearance K823048 on December 15, 1982, through the traditional pathway after a 61-day review. It is manufactured by Seamed Corp. and is authorized for distribution in the United States.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823048 | Date15 Dec 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3600
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Seamed Corp.
Questions
What is the Sea Med Model 880 used for?
The Sea Med Model 880 is designed to generate electrical pulses for cardiac pacing in external applications, meaning it is used outside the body to regulate heart rhythm through temporary pacing.
How was the Sea Med Model 880 authorized for use in the United States?
The device received FDA 510(k) clearance K823048 on December 15, 1982, through the traditional pathway after a 61-day review, demonstrating it was substantially equivalent to a legally marketed predicate device.
Who manufactures the Sea Med Model 880 and where is it made?
The Sea Med Model 880 is manufactured by Seamed Corp., with manufacturing and registration details tied to facilities in McHenry, Illinois, United States, as indicated in the device’s establishment registration data.