The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Models 4400 & 4700 Esophageal Stethoscope Temp.
Device ID | K893409 |
510k Number | K893409 |
Device Name: | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP |
Classification | Stethoscope, Esophageal, With Electrical Conductors |
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 | BZT |
CFR Regulation Number | 868.1920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-10 |
Decision Date | 1989-07-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884838006908 | K893409 | 000 |
20884838006892 | K893409 | 000 |
20884838006885 | K893409 | 000 |