510(k) K915381

PORTABLE OXYGEN GENERATOR by Aequitron Medical, Inc. — Product Code CAW

K915381 is an FDA 510(k) premarket notification submitted by Aequitron Medical, Inc. for the device "PORTABLE OXYGEN GENERATOR". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Aequitron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
November 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type