510(k) K853280

FOUR CHANNEL PH PROBE by Akron City Hospital — Product Code FFT

K853280 is an FDA 510(k) premarket notification submitted by Akron City Hospital for the device "FOUR CHANNEL PH PROBE". The FDA issued a decision of Substantially Equivalent on December 2, 1985. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Akron City Hospital has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1985
Date Received
August 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ph, Stomach
Device Class
Class I
Regulation Number
876.1400
Review Panel
GU
Submission Type