The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Model 790 Tele-thermometer.
Device ID | K853551 |
510k Number | K853551 |
Device Name: | YSI MODEL 790 TELE-THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
Contact | Henry Sostman |
Correspondent | Henry Sostman YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-26 |
Decision Date | 1985-09-19 |