Submission Details
| 510(k) Number | K050014 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 03, 2005 |
| Decision Date | May 05, 2005 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
HEMONIR TM
May 2005
Decision
122d
Days
Class 2
Risk
About This 510(k) Submission
K050014 is an FDA 510(k) clearance for the HEMONIR TM, a Oximeter To Measure Hemoglobin (Class II — Special Controls, product code GLY), submitted by Nir Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on May 5, 2005, 122 days after receiving the submission on January 3, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.
Device Classification
| Product Code | GLY — Oximeter To Measure Hemoglobin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7500 |
Manufacturer
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