510(k) K021366
K021366 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "MAC-LAB/CARDIOLAB EP/COMBOLAB". The FDA issued a decision of Substantially Equivalent on July 3, 2002. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2002
- Date Received
- April 30, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type