510(k) K952222

NELLCOR N-20PA PORTABLE PULSE OXIMETER by Nellcor, Inc. — Product Code DQA

K952222 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "NELLCOR N-20PA PORTABLE PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on August 15, 1995. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nellcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
May 12, 1995
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