510(k) K915158
K915158 is an FDA 510(k) premarket notification submitted by Ipax, Inc. for the device "SUREBREATH DOME, E-Z BREATHER". The FDA issued a decision of Substantially Equivalent on February 12, 1992. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Ipax, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1992
- Date Received
- November 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type