SELECTRODE SYSTEM
FDA 510(k) clearance K832634 · decided 1984-01-25
Clearance details
- K-number
- K832634
- Device name
- SELECTRODE SYSTEM
- Applicant
- Bio-Stimu Trend Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-04
- Decision date
- 1984-01-25
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- BWK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| PANTHEON ELECTROSTIMULATOR (K133980) | Pantheon Research | 2014-11-07 |
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| P-STIM (K140788) | Biegler GmbH | 2014-06-27 |
| JIAJIAN CMN STIMULATOR (K130768) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-08-16 |
| JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (K122812) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-04-11 |
Recalls involving this device
No recalls on record reference this clearance.