510(k) K990574
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