510(k) K022031

NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 by Draeger Medical, Inc. — Product Code BSZ

K022031 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2". The FDA issued a decision of Substantially Equivalent on August 29, 2002. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2002
Date Received
June 21, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type