The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Ambi-24 Ph/pressure Monitor.
| Device ID | K854514 |
| 510k Number | K854514 |
| Device Name: | AMBI-24 PH/PRESSURE MONITOR |
| Classification | Electrode, Ph, Stomach |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | John J Spie |
| Correspondent | John J Spie BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1986-02-24 |