510(k) K990574

STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 by Respironics, Inc. — Product Code MNT

K990574 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964". The FDA issued a decision of ST on May 24, 1999. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Respironics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
May 24, 1999
Date Received
February 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sv70 Ventilator
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type