The following data is part of a premarket notification filed by Innovative Medical Products, Inc. with the FDA for Uph-2000 Universal Oximetry Probe Holder.
Device ID | K914538 |
510k Number | K914538 |
Device Name: | UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER |
Classification | Oximeter |
Applicant | INNOVATIVE MEDICAL PRODUCTS, INC. 825 ROSELAND PKWY. Hrahan, LA 70123 |
Contact | Charles D Mayeux |
Correspondent | Charles D Mayeux INNOVATIVE MEDICAL PRODUCTS, INC. 825 ROSELAND PKWY. Hrahan, LA 70123 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-11 |
Decision Date | 1992-07-14 |