510(k) K042463
K042463 is an FDA 510(k) premarket notification submitted by Rozinn Electronics, Inc. for the device "HOLTER PLUS". The FDA issued a decision of Substantially Equivalent on September 22, 2004. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Rozinn Electronics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2004
- Date Received
- September 13, 2004
- 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