510(k) K024300
K024300 is an FDA 510(k) premarket notification submitted by Oridion Medical 1987 , Ltd. for the device "MICROCAP PLUS/NPB-75". The FDA issued a decision of Substantially Equivalent on April 3, 2003. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Oridion Medical 1987 , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2003
- Date Received
- December 24, 2002
- Clearance Type
- Special
- 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