510(k) K964408
K964408 is an FDA 510(k) premarket notification submitted by Instromedix, Inc. for the device "POSEIDON CARDIAC MONITORING SYSTEM (PCMS)". The FDA issued a decision of Substantially Equivalent on July 23, 1997. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Instromedix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1997
- Date Received
- November 4, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type