510(k) K955013
K955013 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "NOVA CO-OXIMETER ANALYZER". The FDA issued a decision of Substantially Equivalent on April 25, 1996. The device falls under product code GLY (Oximeter To Measure Hemoglobin), a Class II device regulated under 21 CFR 864.7500. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1996
- Date Received
- November 1, 1995
- 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