Oximeter To Measure Hemoglobin
The Oximeter to Measure Hemoglobin is an instrument used in hematology to quantify hemoglobin concentration in blood by measuring light absorption at specific wavelengths, an essential test for diagnosing anemia and monitoring oxygen-carrying capacity. It is classified as FDA Class 2 (moderate risk), subject to general and special controls and requires 510(k) clearance. The product code is GLY, regulated under 21 CFR 864.7500 in the Hematology specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- GLY
- Device Class
- FDA class 2
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050014 | HEMONIR TM | May 05, 2005 | Substantially Equivalent | NIR DIAGNOSTICS, INC. |
| K993104 | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR | Dec 02, 1999 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K955013 | NOVA CO-OXIMETER ANALYZER | Apr 25, 1996 | Substantially Equivalent | NOVA BIOMEDICAL CORP. |
| K952725 | MULTICHECK | Feb 20, 1996 | Substantially Equivalent | RADIOMETER AMERICA, INC. |
| K895466 | AVL MODEL 912 CO-OXYLITE | Nov 06, 1989 | Substantially Equivalent | AVL SCIENTIFIC CORP. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.