Cleared Traditional

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

K972158 · Princeton Regulatory Assoc. · General Hospital

Feb 1998

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K972158 is an FDA 510(k) clearance for the GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Princeton Regulatory Assoc. (Princeton, US). The FDA issued a Cleared decision on February 20, 1998, 256 days after receiving the submission on June 9, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K972158 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 1997
Decision Date	February 20, 1998
Days to Decision	256 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement