THERMOPLATE
FDA 510(k) clearance K991263 · decided 1999-07-08
Clearance details
- K-number
- K991263
- Device name
- THERMOPLATE
- Applicant
- Tokai Hit Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-13
- Decision date
- 1999-07-08
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- MQG
- Device class
- 2
- Regulation number
- 884.6120
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Fujinomiya-Shi, Shizuoka-Ken, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.