510(k) K894627
K894627 is an FDA 510(k) premarket notification submitted by Integrated Display Technology, Ltd. for the device "BT-338N ELECTRONIC CLINICAL THERMOMETER". The FDA issued a decision of Substantially Equivalent on October 23, 1989. The device falls under product code FCI (Punch, Biopsy), a Class II device regulated under 21 CFR 876.1075. Integrated Display Technology, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1989
- Date Received
- July 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type