510(k) K895185

FIRST MEDIC MODEL 610P by First Medical Devices Corp. — Product Code LDD

K895185 is an FDA 510(k) premarket notification submitted by First Medical Devices Corp. for the device "FIRST MEDIC MODEL 610P". The FDA issued a decision of Substantially Equivalent on October 27, 1989. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. First Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1989
Date Received
August 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type