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 |