510(k) K954731
K954731 is an FDA 510(k) premarket notification submitted by P.K. Morgan , Ltd. for the device "OXYLOG 2". The FDA issued a decision of Substantially Equivalent on January 6, 1997. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. P.K. Morgan , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1997
- Date Received
- October 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Oxygen-Uptake
- Device Class
- Class II
- Regulation Number
- 868.1730
- Review Panel
- AN
- Submission Type