The following data is part of a premarket notification filed by Instrument Technology, Inc. with the FDA for Combiscope.
Device ID | K852655 |
510k Number | K852655 |
Device Name: | COMBISCOPE |
Classification | Monitor, Ultrasonic, Fetal |
Applicant | INSTRUMENT TECHNOLOGY, INC. 1961 OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
Contact | Robert Tetrault |
Correspondent | Robert Tetrault INSTRUMENT TECHNOLOGY, INC. 1961 OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
Product Code | KNG |
CFR Regulation Number | 884.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-24 |
Decision Date | 1986-02-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COMBISCOPE 74321989 1944426 Dead/Cancelled |
FLUKE CORPORATION 1992-10-09 |