510(k) K905310
K905310 is an FDA 510(k) premarket notification submitted by Catalyst Research Corp. for the device "MINIOX V PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on May 28, 1991. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Catalyst Research Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1991
- Date Received
- November 28, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type