The following data is part of a premarket notification filed by Intl. Biomedics, Inc. with the FDA for Ambulatory Ph Data Recorder System, Aph-2000.
| Device ID | K882551 |
| 510k Number | K882551 |
| Device Name: | AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | INTL. BIOMEDICS, INC. 7651 AIRPORT BLVD. Houston, TX 77061 |
| Contact | Benno L Dunn |
| Correspondent | Benno L Dunn INTL. BIOMEDICS, INC. 7651 AIRPORT BLVD. Houston, TX 77061 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-21 |
| Decision Date | 1988-10-12 |