The following data is part of a premarket notification filed by Invivo Research Labs, Inc. with the FDA for Omni-trak.
| Device ID | K864889 |
| 510k Number | K864889 |
| Device Name: | OMNI-TRAK |
| Classification | Plethysmograph, Impedance |
| Applicant | INVIVO RESEARCH LABS, INC. 3061 W. ALBANY ST. Tulsa, OK 74012 |
| Contact | John K Mccreery |
| Correspondent | John K Mccreery INVIVO RESEARCH LABS, INC. 3061 W. ALBANY ST. Tulsa, OK 74012 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-12 |
| Decision Date | 1987-03-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OMNI-TRAK 78056111 2707077 Dead/Cancelled |
Leemis Marketing Consultants Inc. 2001-03-31 |
![]() OMNI-TRAK 75198058 not registered Dead/Abandoned |
INVIVO RESEARCH, INC. 1996-11-14 |