BSD-200
by Bsd Medical Corp. 510(k)
Active
510(k) K833158
Overview
The BSD-200 is a medical system designed to deliver radio frequency or microwave energy. It is intended for the treatment of cancer and other medical conditions.
This device is supplied by Bsd Medical Corp. and has received FDA 510(k) clearance under K833158. It is categorized under product code FLL for use in a general hospital setting.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833158 | Date30 Mar 1984 | 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- Withdrawn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
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bsd Medical Corp.
Questions
What is the primary function of the BSD-200 system?
The BSD-200 is a medical system engineered to deliver radio frequency or microwave energy. It is intended for use in the treatment of cancer and other medical conditions within a general hospital setting.
What is the regulatory status of the BSD-200?
The BSD-200 has received FDA 510(k) clearance under K833158. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
Who is the manufacturer of the BSD-200?
The BSD-200 is manufactured by Bsd Medical Corp., located in McHenry, Illinois. The device is categorized under product code FLL for clinical use.