THERMOPULS E
FDA 510(k) clearance K844416 · decided 1985-03-12
Clearance details
- K-number
- K844416
- Device name
- THERMOPULS E
- Applicant
- Nemectron Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-14
- Decision date
- 1985-03-12
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- IMJ
- Device class
- 2
- Regulation number
- 890.5290
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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| SW-THERM (K131899) | Shenzhen Dongdixin Technology Co., Ltd. | 2014-03-14 |
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Recalls involving this device
No recalls on record reference this clearance.