The following data is part of a premarket notification filed by Integrated Display Technology, Ltd. with the FDA for Bt-338n Electronic Clinical Thermometer.
| Device ID | K894627 |
| 510k Number | K894627 |
| Device Name: | BT-338N ELECTRONIC CLINICAL THERMOMETER |
| Classification | Punch, Biopsy |
| Applicant | INTEGRATED DISPLAY TECHNOLOGY, LTD. 41, MAN YUE ST., KAISER ESTATE BLOCK C, 9/F, HUNG HOM, Kowloon, Hong Kong, HK |
| Contact | Chan (mrs.) |
| Correspondent | Chan (mrs.) INTEGRATED DISPLAY TECHNOLOGY, LTD. 41, MAN YUE ST., KAISER ESTATE BLOCK C, 9/F, HUNG HOM, Kowloon, Hong Kong, HK |
| Product Code | FCI |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-23 |