The following data is part of a premarket notification filed by Akron City Hospital with the FDA for Four Channel Ph Probe.
| Device ID | K853280 |
| 510k Number | K853280 |
| Device Name: | FOUR CHANNEL PH PROBE |
| Classification | Electrode, Ph, Stomach |
| Applicant | AKRON CITY HOSPITAL Akron, OH 44309 |
| Contact | Vincent J Greczanik |
| Correspondent | Vincent J Greczanik AKRON CITY HOSPITAL Akron, OH 44309 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-12-02 |