510(k) K780850
K780850 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "SEARLE NEONATAL OXYGEN PROBE". The FDA issued a decision of Substantially Equivalent on August 23, 1978. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Will Ross Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1978
- Date Received
- May 22, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device Class
- Class II
- Regulation Number
- 868.1200
- Review Panel
- AN
- Submission Type