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 |