510(k) K933836
K933836 is an FDA 510(k) premarket notification submitted by Artel, Inc. for the device "HBM HEMOGLOBINOMETER". The FDA issued a decision of Substantially Equivalent on March 31, 1994. The device falls under product code GIG (Hemoglobinometer), a Class II device regulated under 21 CFR 864.7500. Artel, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1994
- Date Received
- August 5, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobinometer
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type