510(k) K051352

OXIMAX NPB-40 HANDHELD PULSE OXIMETER by Nellcor Puritan Bennett, Inc. — Product Code DQA

K051352 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "OXIMAX NPB-40 HANDHELD PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on August 11, 2005. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nellcor Puritan Bennett, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2005
Date Received
May 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type