The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Disposable Temperature Probes (several Models).
Device ID | K883793 |
510k Number | K883793 |
Device Name: | DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) |
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 | 1988-09-07 |
Decision Date | 1988-11-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884838008483 | K883793 | 000 |
20884838006878 | K883793 | 000 |
20884838001033 | K883793 | 000 |