Identity
- Trade Name
- BSD 1000 HYPERTHERMIA SYSTEM FDA PMA
- Generic Name
- System, rf/microwave hyperthermia, cancer treatment FDA PMA
Identifiers
- PMA Number
- P820088 FDA PMA
- FDA Product Code
- LOC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S003 FDA PMA
The BSD-500 Hyperthermia System is an RF/microwave hyperthermia system designed for cancer treatment. It is classified as a Class III medical device under the generic name 'System, rf/microwave hyperthermia, cancer treatment'.
This system was received by the FDA on September 4, 1984, and approved on October 29, 1984, under PMA number P820088 with supplement S003. It is manufactured by Pyrexar Medical, Inc. in Salt Lake City, Utah, and is intended for use in clinical settings as specified in its regulatory authorization.
Frequently asked questions
What type of cancer treatment does the BSD-500 Hyperthermia System provide?
The BSD-500 Hyperthermia System provides RF/microwave hyperthermia treatment for cancer, as defined by its generic name and device classification in the FDA PMA documentation.
Who manufactures the BSD-500 Hyperthermia System and where is it located?
The BSD-500 Hyperthermia System is manufactured by Pyrexar Medical, Inc., located at 1825 W. Research Way, Suite E, Salt Lake City, UT 84119, as stated in the manufacturer and address fields of the device data.
What regulatory authorization does the BSD-500 Hyperthermia System have?
The BSD-500 Hyperthermia System has FDA Premarket Approval (PMA) under number P820088, with supplement S003, and was approved on October 29, 1984, following receipt on September 4, 1984.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P820088 | Class III | Active |
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Manufacturer
- Manufacturer
- Pyrexar Medical, Inc.
Sources (1)
- FDA PMA P820088 24 fields · synced Sep 18, 2026