510(k) K915699

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

K915699 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "NELLCOR PORTABLE PULSE OXIMETER MODEL N-20". The FDA issued a decision of Substantially Equivalent on May 27, 1993. 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
May 27, 1993
Date Received
December 23, 1991
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