510(k) K894100
K894100 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "OXYTRAK(TM) PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on May 9, 1990. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Critikon Company, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1990
- Date Received
- June 9, 1989
- 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