The following data is part of a premarket notification filed by Omp Laboratories, Inc. with the FDA for Cuff Pacer.
Device ID | K780703 |
510k Number | K780703 |
Device Name: | CUFF PACER |
Classification | Monitor, Air Embolism, Ultrasonic |
Applicant | OMP LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBA |
CFR Regulation Number | 868.2025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-25 |
Decision Date | 1978-07-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CUFF PACER 73194166 1166352 Dead/Cancelled |
OMP Laboratories, Inc. 1978-11-21 |