510(k) K895274
K895274 is an FDA 510(k) premarket notification submitted by Global Business, Inc. for the device "HYPEX". The FDA issued a decision of Substantially Equivalent on February 23, 1990. The device falls under product code BYW (Device, Rebreathing), a Class I device regulated under 21 CFR 868.5675.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1990
- Date Received
- August 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Rebreathing
- Device Class
- Class I
- Regulation Number
- 868.5675
- Review Panel
- AN
- Submission Type