The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Precision 4000 Thermometer.
Device ID | K910718 |
510k Number | K910718 |
Device Name: | YSI PRECISION 4000 THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
Contact | Fred Breidt |
Correspondent | Fred Breidt 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 | 1991-02-20 |
Decision Date | 1991-04-09 |