PANTHEON ELECTROSTIMULATOR
FDA 510(k) clearance K133980 · decided 2014-11-07
Clearance details
- K-number
- K133980
- Device name
- PANTHEON ELECTROSTIMULATOR
- Applicant
- Pantheon Research
- Decision
- Substantially Equivalent
- Date received
- 2013-12-27
- Decision date
- 2014-11-07
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- BWK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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| Electro Auricular Device (K140530) | Navigant Consulting, Inc. | 2014-10-02 |
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| 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 |
| MULTI-PURPOSE HEALTH DEVICE (K093322) | Upc Medical Supplies, Inc. Dba United Pacific Co. | 2010-08-05 |
Recalls involving this device
No recalls on record reference this clearance.