510(k) K032519
K032519 is an FDA 510(k) premarket notification submitted by Itamar Medical for the device "ENDO PAT 2000". The FDA issued a decision of Substantially Equivalent on Nov 12, 2003. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Itamar Medical has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 12, 2003
- Date Received
- Aug 15, 2003
- Clearance Type
- Traditional
- 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
- 510(k)