Product code LOC
- Device name
- System, Rf/Microwave Hyperthermia, Cancer Treatment
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P820088S017 | BSD-500 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 2004-01-20 |
| P820088S016 | BSD-500 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 2003-10-08 |
| P820088S014 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1991-11-26 |
| P820088S008 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1991-03-28 |
| P840015S014 | CLINI-THERM MARK I/IV/ DIPOLE ARRAY APPLICATOR | Clini-Therm Corp. | 1990-07-17 |
| P820088S011 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1990-06-21 |
| P840015S013 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1988-12-15 |
| P820088S006 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1988-12-13 |
| P840015S012 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1988-08-22 |
| P840015S011 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1988-04-05 |
| P840015S010 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1988-02-29 |
| P840015S008 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1988-02-19 |
| P840015S006 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1988-01-21 |
| P840015S009 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1987-12-29 |
| P840015S007 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1987-12-29 |
| P840015S005 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1987-12-18 |
| P820088S005 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1986-09-23 |
| P840015S004 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1986-06-12 |
| P840015S003 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1986-04-15 |
| P840015S002 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1985-12-13 |
| P840015S001 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1985-10-31 |
| P820088S004 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1985-10-01 |
| P840015 | CLINI-THERM MARK I/IV | Clini-Therm Corp. | 1985-08-16 |
| P820088S003 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1984-10-29 |
| P820088S002 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1984-07-24 |
| P820088S001 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1984-01-27 |
| P820088 | BSD 1000 HYPERTHERMIA SYSTEM | Pyrexar Medical, Inc. | 1983-11-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00864445000434 | BSD-500 Hyperthermia System | Pyrexar Medical Inc. | 2023-07-18 |
| 08644450004342 | BSD-500 Hyperthermia System | Pyrexar Medical Inc. | 2023-05-24 |
| 06971591765675 | Selethru NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2021-09-20 |
| 00851551005194 | BSD-500 Hyperthermia System | BSD MEDICAL CORPORATION | 2014-09-24 |