510(k) K053369
K053369 is an FDA 510(k) premarket notification submitted by Huntleigh Healthcare for the device "MEDILOG DARWIN HOLTER ANALYSIS". The FDA issued a decision of Substantially Equivalent on December 22, 2005. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Huntleigh Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2005
- Date Received
- December 5, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type