510(k) K931484

REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S by Portable Power Systems, Inc. — Product Code BZD

K931484 is an FDA 510(k) premarket notification submitted by Portable Power Systems, Inc. for the device "REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S". The FDA issued a decision of Substantially Equivalent on February 17, 1994. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Portable Power Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1994
Date Received
March 24, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type