510(k) K992706
K992706 is an FDA 510(k) premarket notification submitted by Galix Biomedical Instrumentation, Inc. for the device "GALIX GBI -3S-LP". The FDA issued a decision of Substantially Equivalent on March 15, 2001. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Galix Biomedical Instrumentation, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2001
- Date Received
- August 12, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type