510(k) K905627
K905627 is an FDA 510(k) premarket notification submitted by Nascor Pty. , Ltd. for the device "NASCOR OXYDOME". The FDA issued a decision of Substantially Equivalent on June 3, 1991. The device falls under product code BYL (Tent, Oxygen), a Class I device regulated under 21 CFR 868.5700. Nascor Pty. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1991
- Date Received
- December 14, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tent, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5700
- Review Panel
- AN
- Submission Type