The following data is part of a premarket notification filed by Amsia Intl., Inc. with the FDA for Amsino Clinical Thermometer.
| Device ID | K960185 |
| 510k Number | K960185 |
| Device Name: | AMSINO CLINICAL THERMOMETER |
| Classification | Thermometer, Clinical Mercury |
| Applicant | AMSIA INTL., INC. 833 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Richard Y Li, Ph.d. |
| Correspondent | Richard Y Li, Ph.d. AMSIA INTL., INC. 833 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-03-28 |