The following data is part of a premarket notification filed by Robert I. Chien & Assoc., Inc. with the FDA for Thermometer (made In China).
| Device ID | K811631 |
| 510k Number | K811631 |
| Device Name: | THERMOMETER (MADE IN CHINA) |
| Classification | Thermometer, Clinical Mercury |
| Applicant | ROBERT I. CHIEN & ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-09 |
| Decision Date | 1981-07-20 |