510(k) K053420
K053420 is an FDA 510(k) premarket notification submitted by Tenacore Holdings, Inc. for the device "TENACORE SP02 SENSORS". The FDA issued a decision of Substantially Equivalent on November 15, 2006. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Tenacore Holdings, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2006
- Date Received
- December 8, 2005
- 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