510(k) K050014
K050014 is an FDA 510(k) premarket notification submitted by Nir Diagnostics, Inc. for the device "HEMONIR TM". The FDA issued a decision of Substantially Equivalent on May 5, 2005. The device falls under product code GLY (Oximeter To Measure Hemoglobin), a Class II device regulated under 21 CFR 864.7500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2005
- Date Received
- January 3, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter To Measure Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type