510(k) K911740

SALTER LABS NEONATAL NASAL OXYGEN CANNULA by Salter Labs — Product Code CAT

K911740 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "SALTER LABS NEONATAL NASAL OXYGEN CANNULA". The FDA issued a decision of Substantially Equivalent on July 24, 1991. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Salter Labs has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1991
Date Received
April 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5340
Review Panel
AN
Submission Type